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Nephrogenic Systemic Fibrosis and Gadolinium—A Medical Record Review with Analysis of Existing Skin and Other Tissue Specimens to Assess Potential Causative or Associated Factors

Objective

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.
IRB Protocol Number
STU00001460
Principal Investigator(s)
Anne Laumann

Clinical Trial Categories

  • Clinical Research

Compensation

  • Not Provided
Sponsor(s)
National Institutes of Health (NIH)
Northwestern University
Contact
Stephanie St. Pierre, MD at 312-695-6786
or s-stpierre@northwestern.edu
How to Participate
  • Those diagnosed with NSF
  • Those who have had a skin biopsy within the Northwestern University Department of Dermatology.