Policies

• You will not be charged if the system is not operational at the time of your study.
• Any excess time used that conflicts with another user’s appointment will be charged to you.
• If your study requires extensive preparation time, arrive early to set up. If you need the magnet to set up, make sure to include time for that when you schedule the study. Consistent failure to adhere to the calendar will not be tolerated.
• You are expected to return all items to their correct place in the magnet room. The counter should be left clear of phantoms or any other debris. Remove the linen bags when they are full.
• The magnet may be used for technical development free of charge after 6 p.m. on weekdays and during the entire day on weekends. Technical development includes phantom scanning for sequence or protocol development, testing paradigm timing and testing the use of equipment such as the auditory and visual stimulus. Studies that collect human data will be charged for the time used.
• Report all incidental findings to CTI. We will review and follow the policy for reporting any findings.
• You must attend the MRI Safety Training program and pass the exam before you can participate in CTI activities or be allowed access to our facilities. Your safety certificate must be renewed annually.
• For safety reasons, at least two researchers must be present for each scan. CTI tech or nurses count only when they are participating in the study and reserved on the calendar.
• There is a 35-day (for neuro) sign-up period on the calendar. If you have a special situation requiring you to schedule a patient beyond 35 days, such as a particular follow-up time, out-of-town subject or a difficult population of a subject, contact Donny Nieto for cardiovascular studies and neuroimaging@northwestern.edu for neurological studies.
• You may schedule a technologist for your studies. Remember to release them when you make changes to your magnet time so others may request their time.

It is recommended that participants with any implants are scheduled at least 2 weeks in advance to allow the principal investigator, their study staff, and CTI staff to appropriately screen for implants that may not be able to be scanned on CTI magnets. Furthermore, if the participant is safety cleared that doesn't mean there won't be artifacts affecting the data quality. In this case the decision to scan is up to the principal investigator of the study.

• Stents found within the coronary arteries are ok to be scanned without detailed information given that the stents are within the coronary arteries/heart only. Documentation stating the stents are of this type will be needed. This could be documented on the screener by the participant.
• Tattoos and/permanent makeup are ok to be scanned. However, it is recommended the scan takes place after the tattoo is healed. There is a risk that that the MRI magnet can distort the tattoos. Non- professional tattoos can be scanned as long as the participant is informed of the risk. The risk includes heating and/or possible burns at the site of the tattoo as well as distortion of the tattoo. Ice packs can be provided upon request prior to the start of the scan, to be placed on the area of potential risk.
• Musculoskeletal implants such as pins, plates, screws or joint replacements (hips, knees, shoulders, etc.) are generally ok to scan without detailed information. If the participant endorses a special implant or one that is adjustable, additional information may be necessary to determine MRI compatibility.
• Cataract lens implants are generally ok to scan without detailed information. However, if a participant endorses a special, programmable or adjustable implant, more information will be required to determine MRI compatibility. 
• Hernia surgery will not require detailed information for umbilical, inguinal or hiatal repair.
• All other passive or active implants including but not limited to stents outside the heart and IVC filters will need to be cleared by CTI staff prior to an MRI being performed. Detailed information includes make, model and location of the implant.
• Persons with metallic fragments, bulletts, BBs, or pellets will require detailed safety screening to determine location of the metallic item. These cases will need to be reviewed and discussed on a case by case basis.
• A prior MRI does not guarantee approval for MRI at CTI even if at the same field strength.
• Clearing an implant for safety does not mean the implant is nonmetallic. Metallic implants in the area of interest can cause substantial artifacts making data unusable. If the principle investigator decides to scan a possible implant that creates substantial artifact yet is safe to be scanned, despite CTI recommendations, the scan will be billed per usual.

Do not register research subjects with any identifying information, such as full names, addresses, medical identification numbers or social security numbers. You should use the study ID that was assigned to the subject when they consented.

Last-minute cancellations and no-shows should be emailed to Donny Nieto, for cardiovascular studies and neuroimaging@northwestern.edu for neurological studies.

Neuro Only

Effective July 2018.

Cardio Only

• Non-repeating slots must cancel the event 24 hours prior to avoid a cancellation. If you cancel less than 24 hours in advance, it will be considered as a cancellation for the month.
• Repeating slots must delete the event seven days prior to avoid a cancellation. If you cancel less than seven days in advance, it will be considered as a cancellation for the month.
• It is recommended that the cancellations be posted to the CTI listserv cti@listserv.it.northwestern.edu. If another group uses the time slot, the cancellation will not count as a cancellation for your study.
• Each PI will be allowed a single cancellation or no-show per month per study. The first cancellation or no-show charge is waived. All other cancellations and no-shows during the same month will be charged a $150 reservation cost.

This policy provides the procedure on MRI research scanners that routinely scan both human and animal subjects.

Human subject and patient use must be first priority. Animal use of the scanners can only occur when it will not conflict with humans being scanned. Humans should never be able to directly see, hear or otherwise identify that animals were or are nearby, or are about to be used in the facility. All procedures must be followed as indicated below.

Persons or Areas Affected

This policy applies to all employees, principal investigators and research affiliates and personnel of the Department of Radiology at Northwestern University involved with non-human primate scans.

Responsibilities

1. The directors of the Center for Translational Imaging are responsible for development and implementation of policies and procedures that address departmental issues and ensure compliance with university and hospital standards.
2. The management team in the Department of Radiology is also responsible for ensuring that all employees comply with these policies and procedures.
3. Employees are responsible for being knowledgeable about and complying with university-wide and department-specific policies.

Procedures

1. Veterinary staff must accompany and provide anesthesia for non-human primate scans.
2. If non-human primates are to be anesthetized and maintained with gas anesthesia, the anesthesia tubing must be provided by the PI prior to scan time. Tubing can remain in the room so long as it is off the floor and contained in a bag. Otherwise, respiratory tubing must be removed from the scanner and control room after each animal scan and stored in the designated area.
3. CTI staff will not handle non-human primates.
4. No non-human primates can be allowed to touch any of the permanent or non-permanent equipment in CTI with the exception of monitoring equipment (ex. SPO2). Therefore, all surfaces that a primate can potentially touch in CTI scanner must be covered with disposable underpads.
5. The lower half of larger animals (non-human primates, dogs, cats, swine, etc.) will be placed in garbage bags to collect bodily waste
6. All surfaces will be thoroughly cleaned with appropriate germicidal cleaner after completion of all non-human primate scans.
7. Any permanent monitoring equipment that is used during a primate scan must be cleaned afterwards using a bacterial and virucidal cleaning product.
8. Air freshener should be used on species that may exude offensive odor such as swine or non-human primates.
9. There will be a minimum of a one-hour rest period for scanner in between animal and human scans.
10. All biohazards will be disposed according to Northwestern University policy.

Responsible Party: Alexander Korutz, MD, Assistant Professor of Radiology

• A single investigator may conduct human research studies only after they have checked in with a staff member of CTI. The investigator must get confirmation from the CTI staff member that they can act as their second investigator. This may present a difficult situation, since the magnet time and volunteer will have to be secured ahead of time. The investigator must be prepared to find a supporting investigator in the event that a CTI staff member is unavailable.
• For contrast studies, the nurse will be present and can count as the second person.
• This does not allow a single investigator to run on the weekends or the evening hours when there is little or no staff available.
• If it is determined that an investigator has scanned on their own or without obtaining confirmation, that investigator will not be allowed to scan in CTI for two weeks. The investigator will also be put on probation requiring them to scan in the presence of an MR technologist. If it happens again, the PI’s entire group will be suspended for two weeks.

Effective December 2008.

Initiation of a Project

All faculty, staff and students must complete the mandatory Safety Training process in order to use the CTI facility.

Renewal

Principal Investigators

Complete the yearly update form that outlines all the changes in policy. The form will also certify that the PI will discuss these policy changes with the PI’s research team. If the PI spends time in CTI, then attendance of the field trip and taking the exam will be encouraged.

Staff & Students

Completion of a yearly recertification. This includes participating in the field trip to CTI and passing the online safety exam. During the field trip, watching the safety video for a second time is not required but is encouraged.

Visitors & Short-Term Observations

A safety-trained PI is allowed to tour the facilities with prospective students or visitors provided they take the appropriate precautions. If a safety-trained PI wants a visitor to observe a research study, they can do so provided the PI is present and responsible for the visitor’s actions. If the visitor is entering the magnet room, they would need to be screened just like a subject.

Effective December 2008.

In accordance with Northwestern University’s Office for Protection of Research Subjects, the university will follow the guidelines for contrast administration set forth by Northwestern Memorial Hospital (NMH). Current NHM policy states, “Prior to a radiology exam requiring gadolinium-based contrast media, all patients will have renal function assessed via estimated glomerular filtration rate (eGFR) on the day of the exam (within 24 hours).”

The Center for Translational Imaging (CTI) uses i-Stat to obtain eGFR results within 24 hours. If you have other means, you will need to demonstrate this information before contrast is administered.

I-STAT

• Point of Care i-STAT testing is a service provided by NMH and will be billed to the PI by NMH.
• The registered nurse (RN) starts IV and draws blood sample from IV for i-STAT testing. Allow 30 minutes for IV start, processing and results.
• Any subjects taking Hydroxyurea also known as Hydrea, Droxia and Mylocel will need to come in 1.5 hours prior to the exam, so the blood can be taken to the lab for process.

Responsible Party: Alexander Korutz, MD, Assistant Professor of Radiology

The purpose of this policy is to ensure the appropriate and safe use of intravascular contrast media in the performance of radiology research procedures. Gadolinium-based contrast agents (GBCAs) have been associated with Nephrogenic Systemic Fibrosis (NSF), a rare but serious systemic disease that is characterized by fibrosis of the skin and other tissues throughout the body in renal-impaired individuals. The policy takes safe practice measures to prevent NSF due to the administration of GBCAs by following recommended guidelines. In an event of a reaction or extravasation to contrast media, a protocol is in place to take immediate response to treat subjects.

Contrast media is administered to enhance the diagnostic potential of imaging. Intravenous contrast can be administered by registered nurses, radiologic technologists and radiologists. Subjects are observed and monitored to minimize clinical risks. It is the policy of the Department of Radiology to provide appropriate and safe care to all subjects.

Persons Affected

This policy applies to all personnel of the Department of Radiology, principal investigators (PIs) and research affiliates, and researchers involved in the injection or monitoring of human subjects receiving intravascular contrast media.

Procedure

A. Contrast media shall be selected, prepared and administered with the following guideline considerations:

• Manufactures’ recommendations
• Institutional Review Board (IRB) approved study protocol
• U.S. Food and Drug Administration (FDA) medication guides
• Appropriate aseptic procedures
• Emergency contrast reaction drug box located in the radiology department areas utilizing contrast media
• Access to 911 for offsite facilities

1. Gadolinium-based contrast agents (GBCAs)
   • Healthy volunteers (HV) will be allowed to participate in one contrast research study per year. Study team will review prior history of HV to ensure only one gadolinium contrast research study has been completed in last year. This restriction reflects sentiments from IRB.
   • Patients are able to participate in contrast research study per year without the one per year restriction. This is consistent with sentiments from IRB.

C. Prior to injecting intravenous contrast media, a radiologist, CTI nurse or technologist shall do the following:

1. Complete an MRI safety questionnaire and obtain relevant health history, including:
   
   • Indications and contra-indications of contrast administration
   • Method of administration and dosing
   • Possible adverse reactions and/or complications
   • Reactions to previous injections of diagnostic contrast media
   • Current medication list pertinent to contrast administration
   • Presence of loose teeth and/or removable dental fixtures
2. Confirm that the emergency drug boxes containing medications to treat contrast reactions are immediately available in the treatment area and that all contents are usable, e.g., have not expired. These are checked daily during weekdays when CTI is operational.
3. For subjects receiving intravenous gadolinium-based contrast media, an estimated glomerular filtration rate (eGFR) will be obtained on the day of the exam using point-of-care testing (defined as within 24 hours), which will be posted in EPIC. The added cost is the PI’s If the eGFR value is less than 30mL/min/1.73m or below the IRB-approved cutoff value, then subject should not receive contrast agent. The study may decide to continue with the examination without contrast agent or simply cancel.
4. Pregnant women should not receive intravenous contrast media in research studies.
5. Research participants with a history of allergy to GBCAs should not receive contrast media.
6. Only radiology nurses, Clinical Research Unit nurses and radiologists will insert and assess peripheral intravenous catheters for the purpose administering contrast media. A nurse will monitor the subjects throughout the infusion process – up to 10 minutes post-injection.
7. MRI technologists may inject a contrast agent by hand or a power injector through peripheral intravenous access established by a registered nurse.
8. For every procedure performed involving the injection of intravenous contrast material, the name, administered dose, route must be documented in the scanner log book.

D. Reporting of Contrast Reactions

1. All contrast reactions, including minor reactions, require immediate notification of the attending physician, physician investigator or medical director of CTI (Daniel Lee, MD) or CTI safety officer (Alexander Korutz, MD) or housestaff radiologist in the cardiovascular imaging reading room (6-1838). If appropriate, orders will be given to the radiology or CRU nurse to treat the reaction. The following may be administered but is not limited to: 50mg Benadryl IV or PO, 125mg Solu-Medrol and Epi IM 0.3mg. The ordering physician should come to CTI to evaluate the patient prior to discharge after any contrast reaction. If the attending radiologist or CTI medical director or CTI MR safety officer or housestaff radiologist believe the reaction to be serious, they will notify the technologist/nurse to contact 911. In the event that a physician cannot be reached, CRU nurses may use their clinical judgement to determine whether to contact 911 .
2. The radiology nurse will record the subject name, the reaction type and the treatment administered for each contrast reaction and will document this in the event log. The PI of the study should be notified.

G. Identifying Reactions

1. Reactions to contrast agents are categorized as minor, moderate or severe by the American College of Radiology (ACR) criteria.
2. Severe reactions include severe and prolonged hypertension, coma, convulsion, pulmonary edema, laryngeal edema, severe bronchospasm and arrhythmia.
3. Moderate reactions can be stable but can also progress to a major reaction. These include hypotension or hypertension of short duration, mild bronchospasm, dyspnea, wheezing or slowly resolving cutaneous reactions such as a rash and urticaria.
4. Minor reactions are often self-limited and treatment is frequently not necessary. Minor reactions include nausea, vomiting, light-headedness, vertigo, dizziness, sweating, itching, urticaria, salivary gland swelling, arm pain, facial edema, chills and sneezing. With all minor reactions, each case must be reviewed. In some instances, the reaction may be a vasovagal response that is related to the stress of the injection, rather than the contrast material itself. Any cutaneous reactions, such as rash, urticaria and itching, should be considered a true reaction even if mild and not treated. Salivary gland swelling and chills should also be carefully evaluated on a case by case basis. The remainder of the “minor reactions” may well not represent a true allergic reactions to contrast agents.
5. Subjects will be assessed by a (CTI or CRU) nurse who will consult with CTI safety officer (Alexander Korutz, MD) or CTI medical director (Daniel Lee, MD) or designated radiology house staff. A (CTI or CRU) nurse will give a “Subject discharge instructions: Contrast Allergy” sheet to the patient. Subjects experiencing a contrast reaction should be seen by a physician prior to discharge and shall be observed by a radiology research or CTI nurse for at least 60 minutes prior to leaving the facility. Subjects will be referred to their primary care physician or the emergency department for post-reaction assessment and care, as needed. Follow-up patient assessment will be made on all subjects (via phone call) by a CTI nurse within 24 hours; a documentation will be uploaded in Epic.

H. Extravasation of Contrast

1. All contrast extravasation events require notification and assessment by the radiology staff (cardiovascular imaging fellow or CTI nurse). Documentation of extravasation is completed on contrast volunteer record form and a copy is maintained in the CTI event log. Subjects are given a “Discharge instructions: Extravasation of contrast media” sheet. Follow-up assessment on all subjects (via phone call) will be made by a CTI nurse within 24 hours; a documentation will be uploaded in EPIC.

• The directors of the CTI, CTI MRI safety officer and CTI medical director are responsible for the development and implementation of policies and procedures that address departmental issues and ensure compliance with Northwestern University policies.
• The management team in the CTI research areas is responsible for defining and facilitating orientation and training for employees and facility users, ensuring training is completed and documented, and ensuring compliance with CTI policies and procedures. The CTI management team also ensures that employees and facility users complete and document training on policy and procedure updates, and complete any required periodic competencies.
• Employees, PIs and research affiliates, Department of Radiology personnel, and other facility users are required to complete CTI-defined orientation and training prior to facility use. After training, they are responsible for compliance with CTI policies and procedures. It is expected that the aforementioned parties are knowledgeable about and compliant with university-wide and department-specific policies relevant to use of CTI but beyond its scope of responsibility.

Policy Update Schedule

This policy will be reviewed every four years or more often as appropriate.

References 

• ACR Manual on Contrast Media, American College of Radiology, Version 10.3, 2018
• Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document on MR Safe Practices: 2013. J Magn Reson Imaging 2013; 37: 501–530.

Cross Reference

NMH policy # NMH RAD 17.0007 version 1.0: Contrast administration and reaction management

Approval

Responsible parties: CTI Research Managers Donny Nieto and Yu Fen Chen

Reviewed by: CTI Director of Cardiovascular Imaging Daniel Kim, PhD; CTI Director of Neuroimaging Todd Parrish, PhD; MRI Safety Officer Alexander Korutz, MD; Medical Director Daniel Lee, MD; CRU Medical Director Anju Peters, MD; CRU Manager Sherri Willoughby, RN, MSN

Approved by: CTI Director Michael Markl, PhD

Effective February 2, 2023.

Additional Forms

• CTI Event Log Form
• CTI Subject Discharge Instructions Form - Extravasation of Contrast Media
• CTI Subject Discharge Instructions - Contrast Allergy Form

The purpose of this policy is to ensure availability of medications for the treatment of allergic reaction in Department of Radiology. Medications to treat contrast allergic reactions are located in the nursing IV start room and in each scanner room.

Persons or Areas Affected

This policy applies to all employees, principal investigators and research affiliates and personnel of the Department of Radiology at Northwestern University Feinberg School of Medicine involved in the injection or monitoring of patients receiving intravenous contrast material.

Responsibilities

• The directors of the Center for Translational Imaging are responsible for development and implementation of policies and procedures that address departmental issues and ensure compliance with university and hospital standards.
• The management team in the Department of Radiology is also responsible for ensuring that all employees comply with these policies and procedures.
• Employees are responsible for being knowledgeable about and complying with university-wide and department-specific policies.

Procedure

1. Emergency contrast reaction medications are located in all radiological areas utilizing contrast material in Olson Pavilion. Emergency contrast reaction medications are located inside every MRI scanner room as well as in the nursing IV start room.
2. When any medication is used, the CTI staff will immediately restock the medications.
3. The medications will be inspected at least once a month for integrity and expired drugs by CTI staff personnel.
4. Pharmacy can be contacted at 6-2174.

Responsible Party: Alexander Korutz, MD, Assistant Professor of Radiology

The intent of this policy is to ensure that all personnel of the Department of Radiology Center for Translational Imaging (CTI) are aware of the procedure for a medical emergency response, including but not limited to: myocardial infarction/angina, seizure, panic attack, thermal injuries/burns, contrast extravasation and reactions to administered drugs occurring to any individual.

Persons or Areas Affected

This policy applies to all personnel in the Department of Radiology as well as principal investigators (PI), research affiliates, researchers, research subjects and visitors in the CTI.

Procedure

A. Activation

In case of a medical emergency:

• If a subject is being scanned, the table top and subject must be moved out of the magnet bore and the subject must be removed from the scan room and transported out in control area to a safe area.
• Close the MRI scan door.
• If trained, administer CPR and AED as appropriate.

1. Dial 9-911
2. Inform the 911 operator of location of facility and be prepared to answer questions about the situation.
   • Location: 710 N. Fairbanks (lower concourse/basement)
   • Cardiovascular CTI – Room 0-235
   • Neuro CTI – Room 0-300
3. Alert Olson Pavilion front desk personnel that 911 was called: 312-926-3119
   • Request personnel at the door to meet and direct first responders to scene.

C. Notify the PI of the study and document in the CTI event log.

Responsibilities

• The directors of the CTI and the CTI MRI safety officer are responsible for the development and implementation of policies and procedures that address departmental issues and ensure compliance with Northwestern University policies.
• The management team in CTI research areas are also responsible for ensuring that all employees comply with these policies and procedures.
• Employees, PIs and research affiliates, personnel of the Department of Radiology, and researchers are responsible for being knowledgeable about and complying with university-wide and department-specific policies.

Policy Update Schedule

This policy will be reviewed every four years or more often as appropriate.

Approval

Responsible parties: CTI Research Managers Donny Nieto and Yu Fen Chen

Reviewed by: CTI Director of Cardiovascular Imaging Michael Markl, PhD, and CTI Director of Neuroimaging Todd Parrish, PhD

MRI Safety Officer: Alexander Korutz, MD

Approved by: CTI Director Andrew Larson, PhD

Effective April 1, 2019.

Additional Form

• CTI EVENT LOG FORM

To establish guidelines and ensure that each female subject is screened for the possibility of pregnancy prior to the performance of a MRI procedure, it is the policy of the Department of Radiology to ensure that all female subjects between the ages of 12 and 60 are screened for the possibility of pregnancy prior to an MRI procedure.

Persons or Areas Affected

This policy applies to all employees, principal investigators and research affiliates and personnel of the Department of Radiology at Northwestern University responsible for monitoring documentation and confirming information and follow-up where appropriate.

Responsibilities

• The directors of the Center for Translational Imaging are responsible for development and implementation of policies/procedures that address departmental issues and ensure compliance with university and hospital standards.
• The management team in the Department of Radiology is also responsible for ensuring that all employees comply with these policies and procedures.
• Employees are responsible for being knowledgeable about and complying with university-wide and department-specific policies.

Procedure

Radiology staff will screen all females via safety questionnaire or pregnancy test (depending on the type of test, non-contrast or contrast MRI) between the ages of 12-60 to determine pregnancy prior to the start if the MRI exam.

Exceptions

• Female subject who have delivered a baby within the last seven days are exempt from pregnancy testing.
• Females who have had a menstrual period within the last four weeks.
• Females who have had a menstrual period over four weeks and do not want to have a pregnancy test can sign a declination form.
• Female subjects who have undergone a hysterectomy are exempt from pregnancy testing.
• Female subjects between the ages of 51-60 who indicate they are not pregnant or trying to become pregnant are exempt from pregnancy testing.
• If the subject is unsure of whether or not they are pregnant and wishes to participate in the study, it is up to the PI’s discretion to determine pregnancy with a urine pregnancy test or decline the subject’s participation.
• Subjects receiving contrast that do not fall under the exception policy will be given a pregnancy test to determine pregnancy.
• Subjects not receiving contrast that do not fall under the exception policy will be screened through the safety questionnaire.
• Pregnant subjects will not be scanned unless specifically indicated by IRB. These subjects will be scanned in accordance to the IRB specific guidelines.
• CTI policy represents a modification of NMH policy as applicable to non-pregnant subjects involved in research studies. Subjects known to be pregnant that are involved in pregnant study will be scanned with the documentation and approval of the IRB.

Cross Reference

NMH Policy: Method for Determination and Documentation for Patient Pregnancy

Responsible Party: Alexander Korutz, MD, Assistant Professor of Radiology

In the event that a subject needs or desires an accompanying individual (spouse, friend, parent, translator, etc.) in the magnet room to facilitate their participation in the study, the accompanying individual must be screened using the MR safety form and must be prepared for entry into the magnet room similarly to the subject by changing into a gown. The individual must be brought into the magnet room by the MR technologist or whomever is conducting the study. They may assist with getting the person in the magnet, but should not touch any of the equipment around the scanner table or in the room. The individual should be encouraged to leave the magnet room when the exam starts; however, if they insist on staying, the plastic transportation cart can be used as a chair for them during the scan. The accompanying individual must wear earplugs and the extra headphones to minimize the noise during the scan. They should be warned not to move around the room or touch any equipment once scanning has begun.

Access to the control room is limited to research personnel only that have passed the CTI safety requirements. This policy is to protect the privacy of subjects and to avoid situations in which the appearance of an obvious lesion or abnormality in the MR images would prompt questions that neither non-clinical research personnel nor the CTI staff would be qualified to answer. We recommend that these types of findings should first be confirmed by a radiologist, and should then be communicated to the subject (or the subject’s authorized representative) by the principal investigator or their designee.

The only exception to this policy is if the principal investigator is personally present in the control room and will be prepared to discuss any findings with the non-research personnel.

Northwestern University has a master research agreement with Siemens Medical Solutions. This agreement gives Northwestern researchers access to proprietary information, software and hardware. This agreement also delineates significant restrictions on disclosures and intellectual property rights including giving Siemens a non-exclusive, royalty-free right to any intellectual property developed utilizing any of the MR scanners in CTI.

If you have any questions, please contact the Innovations and New Ventures Office or INVO (formerly the Technology Transfer Office) at Northwestern.

It must be made clear to the subject via the consent form and verbal reinforcement that the images will not be formally reviewed. The purpose of their participation in the research study should not be to obtain medical information. However, if a researcher or their students or staff should notice something that is potentially abnormal, this information should be forwarded to the collaborating MD and to a CTI tech. The tech will document the incident in the event log book, which will show the date observed, the study name, the radiologist reviewing the images and the final outcome and recommendations. The subject should not be informed about the abnormality at the time of scanning in order to eliminate any risk of anxiety for no reason. The CTI staff will have a radiologist review the research images. Information about the subject may be required in order for the radiologist to make an informal reading. This exchange will be facilitated by the techs. If the suspected abnormality is normal, there is nothing else to do. If the finding requires a follow-up, the findings will be reported back to the PI. The PI should either contact the subject or the subject’s physician depending on what the subject desires. An incidental letter will be mailed to the subject. In cases where the study has a process for incidental findings, the study will send out the letter according to their study protocol.

Flow chart of events:

1. Images are taken.
2. The researcher or their staff, tech or other radiology personnel may notice a potential abnormality without disclosing to the subject.
3. Tech records the incident in the event log book.
4. The de-identified images are forwarded to the MD on the project or to an appropriate radiologist for review.
5. A determination is made by the radiologist, either medically insignificant or medically significant.
6. If the finding is medically significant, an incidental letter will be mailed to the subject.

Responsible Party: Alexander Korutz, MD, Assistant Professor of Radiology

Due to the number of investigators and limited staff, the neuroimaging team at CTI offers the option of additional scanner training, which allows the trainee to operate the scanner without technician assistance.

Please keep in mind that this option is only offered to Northwestern users. Scanner training is offered exclusively through the neuro CTI technician Rachael Young. Any unofficial training through non-CTI staff is strictly forbidden and will result in revocation of scan privileges for the ENTIRE GROUP.

To request additional scanner training:

1. Discuss with Rachel about your need for tech training. Since it’s a significant time burden, we’d like to limit this to people who really need it and have no alternative means for scan coverage.
2. Principle investigator must send an email to neuroimaging@northwestern.edu, specifying the name of the trainee and the study. The training charge is two hours of scan time per trainee.
3. Once approved, Rachael will reach out to schedule the first two-hour session on the neuro calendar under the appropriate study. The two-hour session is intended to be one-on-one.
4. After the two-hour session is completed, the trainee needs to document at least 20 supervised scans/hours (whichever is longer). Supervision can be done by Rachael or another certified operator. A supervisor needs to sign off on the scan log and is responsible for the trainee’s final performance on the qualifier test. Please confirm with Rachael that the supervisor is certified before proceeding with supervision. If the supervisor is not a certified operator, logged hours will not be accepted.
5. Trainees must pass a qualifier test where Rachael will observe them scan a real subject for their study. If the trainee fails the qualifier, they must continue to accrue supervised scan hours and retake the qualifier until they pass.
6. Annual supervised renewal needs to be scheduled with Rachael.
7. Trainees who have not operated the scanner for more than a month should schedule a refresher session with Rachael before scanning again.

Some studies performed in CTI utilize vasodilator stress testing to evaluate the extent and severity of coronary artery stenosis. Although the safety of stress testing is well established, procedures and guidelines are necessary to ensure that CTI has the appropriate medications, equipment and staff to respond in a prompt and effective manner to a medical emergency that could arise.

The NMH Rapid Response Team and Cardiac Arrest Team do not cover CTI. Therefore, the study team is responsible for assessing the patient and providing emergency medical care according to ACLS guidelines until EMS arrives. The American Heart Association has published recommendations for emergency preparedness that apply to outpatient stress testing laboratories.

Personnel

To ensure adequate patient monitoring and response to medical emergencies, one individual fulfilling each of the following qualifications must be present for cardiovascular stress testing in CTI. These three individuals are the minimum; additional personnel are allowed provided the number of people in the MRI control room does not interfere with patient monitoring tasks.

1. ACLS-certified RN
2. ACLS certified cardiologist
3. MRI Technologist

Equipment

To ensure adequate patient monitoring and response to medical emergencies, appropriate equipment will be maintained in CTI by the CTI research manager. See: "CTI Equipment Appendix."

Emergency Drugs & Solutions

1. To enable supervising staff to initiate ACLS protocols while awaiting EMS arrival, CTI will stock the necessary medications to perform ACLS algorithms.
2. ACLS drugs are located in “CTI ACLS Drug Box” in MRI control room maintained by the CTI research manager. See: "CTI ACLS Drug Box Appendix."
3. Drugs used for gadolinium or benzodiazepine reactions are located in “NMH Adult Emergency Box” - red box in MRI control room maintained by CTI research manager. See: "NMH Adult Emergency Box Appendix."

Responsibilities & Procedures

A. Daily safety checklist

1. CTI manager or MRI technologist will complete the “Emergency Response Roller Stand Monitor/Defibrillator/Equipment Daily Checklist” each day prior to patient scans, adding date and initial to the checklist.

B. Routine safety measures during stress test study visits

1. eEmergency medications present in control room.
2. MRI tech attaches blood pressure cuff and SPO2 monitor.
3. HR, BP, SpO2 monitored approximately every minute during adenosine infusion and for 10 minutes after completion of adenosine infusion.
4. RN and MD both present (in the control room or scanner room) for adenosine infusion and at least 10 minutes after completion of adenosine infusion to monitor for adenosine-related adverse reactions.

C. In the event of a medical emergency:

1. If a subject is being scanned, the tabletop and subject must be moved out of the magnet bore and the subject must be removed from the scan room and transported out in control area to a safe area.
2. Close the MRI scan door.
3. The MRI technologist or another study team member dials 9-911 to request EMS while RN and MD provide ACLS care.
4. The caller must inform the 911 operator of location of facility and be prepared to answer questions about the situation.
   • Location: 710 N. Fairbanks (lower concourse/basement)
   • Cardiovascular CTI – Room 0-235
5. Alert Olson front desk personnel that 911 was called: 312-926-3119
6. Have personnel at the door to meet and direct first responders to scene.

Applicable Regulations

• Myers et al. Recommendations for Clinical Exercise Laboratories:A Scientific Statement From the American Heart Association. Circulation. 2009;119:3144-3161.
• Myers et al. Supervision of Exercise Testing by Nonphysicians: A Scientific Statement From the American Heart Association. Circulation. 2014;130:1014-1027.

• CTI Equipment Appendix
• CTI ACLS Drug Box Appendix
• NMH Adult Emergency Box Contents
• Emergency Response Roller Stand Monitor/Defibrillator/Equipment Daily Checklist

Approvals

Written by: Medical Director Daniel Lee, MD

Approved by: CTI Director of Cardiovascular Imaging Daniel Kim, PhD; CRU Medical Director Anju Peters, MD

Effective October 1, 2022.