Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). Because the FDA released guidance for gadolinium contrast agents, the guidance below should be followed when GBCAs are part of the research.
Under the section, “What are the risks of being in this study? Is there any way being in this study could be bad for me?”:
- Include the risk of and a description of Nephrogenic Systemic Fibrosis (NSF),
- Specify the product name and dosage,
- Advise participants to avoid receiving additional gadolinium within 24 hours before or after the research dose,
- Include all restrictions in the Boxed Warning section of the most recent full prescribing information, and
- Include the following language:
- Deposits of gadolinium remain in the brains of some patients who have undergone 4 or more MRI scans with gadolinium for a prolonged time after the last administration.
- Deposits of gadolinium have also been reported in skin and bone. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
- The FDA-mandated Boxed Warning specifies: “do not exceed the recommended dose”. If the gadolinium dosage for research administration is higher than the dosage specified in the full prescribing information, protocol-specific FDA documentation of exemption from an IND is required for the IRB panel determination.
- Review FDA IND Exemption for protocol-specific guidance: INDs — Determining Whether Human Research Studies Can Be Conducted Without an IND
Healthy Control Participants
For projects with healthy participants where the FDA indication does not apply, the protocol and consent need to:
- include a screen for participants with acute kidney injury and other conditions that may reduce renal function,
- address the Boxed Warning restrictions,
- ensure that the recommended GBCA dose is not exceeded,
- allow a sufficient period of time for elimination of the drug from the body prior to any re-administration, and
- include language that specifies:
- the dosing information,
- creatinine clearance restrictions, and
- avoidance of repeated GBCA in the 24-hour period before and after.
GBCA dosing must be consistent with FDA Box Warning labelling as follows:
- Magnevist: Do not exceed dosing of 0.1mmol/kg (0.2ml/kg)
- Multihance: Do not exceed dosing of 0.1mmol/kg (0.2ml/kg)
- Ablavar: Do not exceed dosing of 0.03mmol/kg (0.12ml/kg)