Nephrogenic Systemic Fibrosis (NSF)
SCOPE:
NSF formally described in 2000 is associated with tissue deposition of collagen with resultant thickening of the skin of the extremities and sometimes the trunk. Fibrosis may also involve the diaphragm, heart, lungs, pulmonary vasculature and skeletal muscle. The association of NSF with gadolinium based agents was initially reported with Omniscan in 2006, later with Magnevist and OptiMARK. As of 01/17/2007, of the 100 cases of NSF reported, 85 are associated with Omniscan, 21 with Magnevist and 6 with OptiMARK. None of the cases have been associated thus far with ProHance or MultiHance. The incidence of NSF seems to be 3-5% in patients with severe renal disease who receive Gadolinium based agents.
While there is no definitive causal relationship between Gadolinium based contrast agents and subsequent development of NSF in patients with severe renal disease who receive Gadolinium for their MRI, the FDA has issued an advisory which can be found on their web page:
http://www.fda.gov/cder/drug/advisory/gadolinium_agents_20061222.htm
RECOMMENDATIONS:
Screening: The ACR Contrast Committee and the Subcommittee for MR Safety members now recommend, as of July 2007, pre-screening patients prior to the administration of Gadolinium-Based MR Contrast Agents (GBMCA). It is recommended that prior to elective Gadolinium Based MR Contrast Agent (GBMCA) administration, a recent (e.g., last 6 weeks) Glomerular Filtration Rate (GFR) be reviewed for patients with a history of:
1. Renal disease (including solitary kidney, renal transplant, renal tumor)
2. Age >60
3. History of Hypertension
4. History of Diabetes
5. History of severe hepatic disease/liver transplant/pending liver transplant. For patients in this category only, it is recommended that the patient's GFR assessment be nearly contemporaneous with the MR examination for which the GBMCA is to be administered.
Gadolinium agents should be used only if absolutely necessary in renal failure
(Stage 3 through 5). Only half dose should be administered in standard studies unless “diagnostic benefit” of larger doses outweighs the risks.
If MRA is absolutely necessary, single dose (0.1 mmol/kg) will be used. Gadolinium doses are typically single dose (0.1 mmol/kg) for non-angiographic studies and double dose (0.2 mmol/kg) for MRA.
Stage 4 and 5 patients must undergo hemodialysis within 2 hours of examination and a second hemodialysis is strongly recommended 24 hours later. Stage 3 patients do not require hemodialysis. Scheduling and coordination with Nephrology will be important for these patients who are at risk.
Gadodiamide (Omniscan) is contraindicated for all renal failure patients.
Stage 1 and 2 patients can undergo standard MRI and MRA procedures with single and double dose based upon standard protocol. No dialysis is required following the procedure.
Stages of Renal Disease
Stage / Description / GFR ml/min/1.73 m21 / Normal / ≥ 90
2 / Mild renal disease / 60-89
3 / Moderate renal disease / 30-59
4 / Severe renal disease / 15-29
5 / Kidney failure / < 15
GFR can be calculated based on the MDRD formula:
http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
It is also recommended that all patients identified with moderate to end stage renal disease
(Stages 3-5), be provided with informed consent which includes a review of known risks
and benefits as well as possible availability of alternative imaging modalities if any.
Should a new diagnosis of NSF be made, it is recommended that the FDA be notified
through their MedWatch Program at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Documentation
The creatinine level, GFR, type and amount of contrast media will be documented by the MRI technologist on the on-line history form.
The creatinine level, GFR, type and amount of contrast media will be dictated into the medical record by the Radiologist.
Consent forms (where appropriate) will be PacScanned into Stentor by the PRA.