UNC's GADOLINIUM POLICY

Preamble:

The condition nephrogenic systemic fibrosis (NSF) has been associated with prior administration of gadolinium chelate contrast administration, the standard contrast agent used in MRI that has also in the past been used in some CT studies.

It appears that NSF arises from deposition of free gadolinium into skin connective tissue and connective tissues of other organs, and it appears that gadolinium stimulates the activity of circulating fibrocytes to deposit collagen into these various tissues. The elements involved appear to be, gadolinium agents that are less stable in the setting of patients who cannot readily eliminate the agents through glomerular filtration due to compromised renal function. The initial descriptions were in patients who were on dialysis and it now appears that anyone with substantially diminished renal function may develop the condition. The two least stable of the gadolinium chelates are Omniscan and Optimark, and these are the agents most associated with NSF. Multihance is now the primary MR contrast agent at UNC. In over 3 million doses of Multihance no “clear” case of NSF has been identified with this agent.

UNC Gadolinium Policy

1. no Omniscan is administered to any patient
2. all patients in renal failure, on dialysis, or with a renal transplant undergo 0.5 dose Multihance
3. all patients suspected of having renal compromise, as ascertained by technologist administered questionnaire, will receive 0.5 dose Multihance. MR technologists have been informed to evaluate patient history on CIS for evidence of renal compromise including sCr and other measures.
4. all third trimester pregnant patients in whom gadolinium is deemed necessary will undergo 0.5 dose Multihance
5. gadolinium will be avoided in 1st and 2nd trimester pregnancies
6. no double dose gadolinium studies will be performed, replaced by single dose Multihance
7. no gadolinium will be used as a substitute for iodine contrast in CT, on angiography, or other X-ray procedures
8. Repeat Gadolinium-enhanced MR studies should be avoided within 48 hours. If a repeat study is necessary within 48 hours, more detailed evaluation of renal function will be necessary. If renal function is moderately compromised repeat gadolinium studies will not be performed, and either noncontrast study will be performed or a delay beyond 48 hours will be necessary.
9. patients with greater than 10 year history of poorly controlled hypertension, greater than 10 year history of insulin-dependent diabetes, and patients older than 70 years of age who are treated for hypertension or diabetes will undergo 0.5 dose Multihance.
10. Patients who are already on hemodialysis should undergo hemodialysis as soon as reasonably feasible following MRI with Multihance. A second hemodialysis at 24 hours is suggested but not mandatory. No patient should receive hemodialysis that is not already on hemodialysis, if the indication for dialysis is the MRI study alone.
11. Modifications of this policy may be implemented on a case by case basis when a risk-benefit analysis has been made and the administration of contrast is deemed medically necessary by the attending radiologist. Such determination will be noted in the patient’s record.

Any questions can be directed to Richard Semelka, MD, Vice Chair of Clinical Research and Director of MR Services at (919) 966-4400.