CAMRIS

Center for Magnetic Resonance Imaging & Spectroscopy


February 2021

**HUP Clinical Research Staff using contrast agents during your MRI Research Scan**

All subjects must be provided the appropriate contrast Medication Guide for review prior to the research scan taking place. All risks are to be explained to the subjects during the consenting process. The Gadolinium Based Contrast Agents (GBCA) Risk Clauses (deposition risk, IV line placement risk, etc) must be included in your consent form under the MRI Risks section. These clauses can be found on our Consent Language Tab on our website. HUP Radiology has also provided a MRI Contrast Flyer for all subjects to review if they are to receive contrast during their MRI scan. Please see the links below for the appropriate forms to download.

If you are unsure of which contrast is administered for your MRI Research scan, please check your MRI protocol or ask your study Radiologist. If you currently running a research protocol through UPENN Radiology Clinical Service, you are now using Dotarem.

Dotarem Medication Guide

Eovist Medication Guide

MultiHance Medication Guide

ProHance Medication Guide

Gadavist Medication Guide

HUP Radiology flyer can be found here: HUP Contrast Flyer

 

May 2019

HUP/UPENN Clinical/Research MRI standard contrast agent is now Dotarem only.

If your existing, active protocol utilizes a different contrast agent, and the study needs to be continued using a non-UPENN-standard agent, please make sure you inform your MRI Research Technologist to use the correct contrast agent.

If you currently running a research protocol through UPENN Radiology Clinical Service you are now using Dotarem. 

If you are starting a new study that requires use of contrast that is not Dotarem, the PI must provide a written explanation as to why this is needed. CAMRIS will review and make a determination if the non-standard contrast choice can be used.

Approved Contrast currently available in HUP Radiology/CAMRIS

 

Dotarem

gadoterate meglumine
(used in instances of lower GFR and/or CVI Imaging studies)

Macrocyclic

 

Non-Standard Contrast agents that may be made available if approved by CAMRIS for your study**

Gadavist

Gadobutrol (used in replacement of Dotarem in specific CVI cases)

Macrocyclic

ProHance

Gadoteridol (used for Neuro Imaging studies)

Macrocyclic

Eovist

gadoxetate disodium
(used for Liver & Body imaging studies)

Linear

MultiHance

gadobenate dimeglumine
(used for Musculoskeletal imaging studies)
 

Linear

**Not regularly stocked, so please ensure you speak to a CAMRIS Research MRI tech at least 3 days prior to your scan date to ensure contrast availability 

 

July 2018

FDA Update Regarding Use of Contrast Agents in MRI (Gadolinium-Based Contrast Agents, ‘GBCAs’)

CAMRIS is informing all researchers to the recent FDA Update regarding use of Gadolinium-Based Contrast agents (GBCAs) in MRIs. The FDA has specifically updated the Prescribing Information due to concerns with gadolinium (a heavy metal) remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

However, the FDA has stated that after additional review and consultation with the Medical Imaging Drugs Advisory Committee, they are requiring several actions to alert health care professionals and subjects about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide*--providing educational information that every subject will be asked to read before receiving a GBCA, in addition to requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.

All research MRI studies that are currently using--or plan to use--a GBCA contrast agent please read the FDA Update found here:

https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm

 

Changes to the CAMRIS Policy Regarding Use of GBCAs in MRI Research

CAMRIS has determined that a reference to these deposition issues must be included in all ICFs for studies that require use of a GBCA. The FDA Update mentions Medication Guides should be provided to subjects. These guides are now available for all subjects requiring a GBCA for their MRI study & should be provided to each research subject during the consenting process.

Dotarem Medication Guide

Eovist Medication Guide

MultiHance Medication Guide

ProHance Medication Guide

Gadavist Medication Guide


Investigator Responsibility
In addition to the revised CAMRIS GBCA Risk Language, it will be up to each Investigator to ensure his/her study teams adequately explain the GBCA risks to each subject during the Informed Consent process.

The new, updated GBCA Risk Language for the ICF which should read as follows:

Retention: Traces of gadolinium may remain in the body long-term after contrast administration. This risk increases with the number of administrations, but reviews to date have not identified adverse health effects from gadolinium retained in the brain or bodily tissues after MRI ([Gadolinium agents administered in this study are thought to minimize or eliminate this risk *]).
If you would like more information, please go to this link https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm or ask the study team for more information.
*excluded for studies using linear GBCA.

When shall I update my study documents?

For current, ongoing CAMRIS studies
Studies that are currently enrolling must modify their ICF with the new CAMRIS GBCA Risk Language within 90 days of the GBCA update notification. Those subjects who will be returning for additional MRI time points must be re-consented with the IRB-approved, updated ICF.

For studies not currently enrolling
Non-enrolling studies can submit this change with another planned modification to update their ICF with the new CAMRIS GBCA Risk Language.
 

Principal Investigators & Study Medical Staff

Updated--CAMRIS GBCA Administration Policy

Macrocyclic agents will be used in all CAMRIS research studies requiring Gadolinium contrast based upon evidence of significantly lower Gadolinium retention from macrocyclic agents versus linear agents.

The following limited exceptions will be considered, but require review and approval by the CAMRIS scientific/safety review process prior to study approval:

  1. Protocols where the research MRI studies are performed in conjunction with clinical MR imaging procedures that use non-macrocyclic agents.
  2. Multi-center protocols specifying a non-macrocyclic agent.
  3. Strong consideration will be given to recommending against non-macrocyclic agents in the above circumstances in the absence of patient benefit-  for example,  clinical interpretation of the research study or requirement for access to a potentially beneficial treatment.

Dose and GFR

Any subject without known renal disease will not need to undergo a creatinine level. CAMRIS will accept attestation of medical history regarding absence of known renal disease.

Any subject with known renal disease of any severity undergoing administration of a contrast agent for research imaging in MRI must have a creatinine level available for the calculation of their GFR. The creatinine level must be within the last 6 months from the date of the research MRI. The most recent creatinine level must be used for the GFR calculation. ISTAT creatinine levels can be made available through arrangement with CAMRIS for a fee. Use of the ISTAT is not part of the scheduled time on MR scanner and will be in addition to the projects’ scheduled slot. Please plan accordingly. This service is charged on a per-session basis. ISTAT values can be used for subsequent scans out to the 6 month limit.

  1. All contrast imaging will be performed using the Clinical Macrocyclic Agent, unless otherwise specified and arranged through CAMRIS by the Investigator.
  2. Any change in dosing as described below must be arranged through CAMRIS.
  3. All GBCA’s administration will follow the clinical standard.
  4. Any GFR calculated below 45ml/g/m3 the Investigator must provide must a signed Gadolinium prescription from a UPENN Radiologist (situation #2,#3 below)* and the prescription must give dose and type of GBCA to be administered.
  1. Subjects with a GFR ≥ 45ml/g/m3 may receive the standard 70% dose of the Clinical Macrocyclic Agent
  2. Subjects with a GFR ≥ 30ml/g/m3 AND < and45ml/g/m3 may receive the standard 50% dose of the Clinical Macrocyclic Agent*
  3. Subjects with a GFR < 30ml/g/m3 call and arrange directly through a Radiologist*
    Pregnant subjects** cannot be administered gadolinium for research. If your protocol seeks to include pregnant subjects and administer gadolinium please contact the IRB.

 

FDA-Approved GBCAs* currently available in HUP Radiology/CAMRIS

Dotarem

gadoterate meglumine
(used in instances of lower GFR and/or CVI Imaging studies)

Macrocyclic

Gadavist

Gadobutrol (used in replacement of Dotarem in specific CVI cases)

Macrocyclic

ProHance

Gadoteridol (used for Neuro Imaging studies)

Macrocyclic

Eovist

gadoxetate disodium
(used for Liver & Body imaging studies)

Linear

MultiHance

gadobenate dimeglumine
(used for Musculoskeletal imaging studies)
 

Linear

 

*Linear GBCAs result in more gadolinium retention in the body than macrocyclic GBCAs.
Gadolinium levels remaining in the body are LOWEST and similar after use of these agents.
 

 

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