Consent Form for IV Gadolinium Contrast
Background:
Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy (NSF/NFD) was first
described in the medical literature in 2000. The first case of NSF/NFD was seen in 1997. The
disease is rare, with only between 250 and 400 cases currently reported. NSF/NFD is seen most
frequently in patients that have advanced renal failure. The disease causes fibrosis of the skin and
connective tissues throughout the body. Patients develop skin thickening that may prevent bending
and extending joints, resulting in decreased mobility of joints. In addition, patients may experience
fibrosis that has spread to other parts of the body such as the diaphragm, muscles in the thigh and
lower abdomen, and the interior areas of lung vessels. The clinical course of NSF/NFD is
progressive and may be fatal. There have been reports suggesting a relationship between the use of
Gadolinium contrast agents and NSF/NFD. At this time, the majority of cases have been associated
with Omni scan or Optimark. There may also be an association with a co-existing pro-inflammatory
event. Gadolinium deposits have been identified in skin biopsies of patients with NSF/NFD. The
FDA has issued an alert regarding the use of gadolinium in patients with renal disease or who are on
dialysis.
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Risks of gadolinium contrast:
Allergic reaction, with less than one in 300,000 chances that this will be severe.
Metallic taste in the mouth, tingling in the arm, nausea, or headache in less than 1% (less
than 1in 100) of people.
Insertion of the needle (small plastic tube) may also cause minor pain, bruising and/or
infection at the injection site.
NSF/ NSD: a rare fibrosing condition of the skin and organs described in more detail
above.
NSF/NFD is most commonly seen in patients with renal failure who undergo an MRI or
MRA with IV gadolinium contrast. It can cause permanent disability and death.
Alternatives:
The MRI or MRA can be performed without IV contrast. In some cases, a CT scan with iodine
contrast or a conventional angiogram may be an alternative.
Your signature below indicates that you have read and understand this page and the risks
described above, including the risk of the rare fibrosing condition NSF/NFD and agree to have an
MRI and/or MRA with IV gadolinium gadolinium contrast.
Signature____________________________________ Date_________________
(Patient or person authorized to consent for the patient)
Witness_____________________________________ Date_________________