Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels

The primary objective of this study is to determine any causative or associated factors for
the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy
(NFD), or related diagnosis. Our primary focus will be on the previous administration of
gadolinium to these patients, but we will also look at other postulated causes and risk
factors.

The secondary objective of this study is to assess tissue gadolinium (Gd) levels in five
groups of subjects:

- Those affected by NSF.

- Those with normal kidney function who have undergone a medical imaging procedure using
Gd-based contrast agent (GBCA) in the 2 years prior to a skin biopsy.

- Those with normal kidney function who have never been exposed to GBCA and have had a
skin biopsy.

- Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have had a medical imaging
procedure using GBCA in the 2 years prior to skin biopsy.

- Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have never been exposed to GBCA
and have had skin biopsy.

We hypothesize that there is a correlation between the administration of Gd-containing
agents usually associated with MRI procedures and the development of NSF in those with renal
failure and some other predisposing condition. We also hypothesize that tissue Gd levels in
those with NSF will be higher than in those who have been exposed to GBCA but do not have
NSF. Of the two groups without NSF but with exposure to GBCA, we hypothesize that those
with kidney dysfunction will have higher tissue Gd levels than those with normal kidney
function. We hypothesize that in the two groups of subjects without exposure to GBCA, there
will be no detectable levels of Gd, regardless of kidney function status.