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

Nephrogenic Systemic Fibrosis Clinical Trial

— NSF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014754
• Other study ID #: STU1460
• Secondary ID: NIH Grant #2 R01
• Status: Completed
• Phase: N/A
• First received: November 13, 2009
• Last updated: December 2, 2014
• Start date: August 2007
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

NSF group

Inclusion Criteria:

• Biopsy-confirmed diagnosis of NSF

Exclusion Criteria:

• Does not have NSF

Normal renal plus gadolinium exposure

Inclusion Criteria:

• eGFR >30

• Existing skin tissue sample

• Gadolinium exposure in 2 years preceding skin biopsy

Exclusion Criteria:

• Does not fit inclusion criteria

Abnormal renal plus gadolinium exposure

Inclusion Criteria:

• eGFR <30 or on dialysis

• Existing skin tissue sample

• Gadolinium exposure in 2 years preceding skin biopsy

Exclusion Criteria:

• Does not fit inclusion criteria

Abnormal renal without gadolinium exposure

Inclusion Criteria:

• eGFR <30 or on dialysis

• Existing skin tissue sample

• No gadolinium exposure ever

Exclusion Criteria:

• Does not fit inclusion criteria

Normal renal without gadolinium exposure

Inclusion Criteria:

• eGFR >30

• Existing skin tissue sample

• No gadolinium exposure ever

Exclusion Criteria:

• Does not fit inclusion criteria

Controls (neonatal)

Inclusion Criteria:

• Existing skin biopsy tissue that was performed within the first 6 months of life

Exclusion criteria:

• Does not fit inclusion criteria

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Fibrosis
• Nephrogenic Fibrosing Dermopathy
• Nephrogenic Systemic Fibrosis

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cowper SE, Robin HS, Steinberg SM, Su LD, Gupta S, LeBoit PE. Scleromyxoedema-like cutaneous diseases in renal-dialysis patients. Lancet. 2000 Sep 16;356(9234):1000-1. — View Citation

High WA, Ayers RA, Chandler J, Zito G, Cowper SE. Gadolinium is detectable within the tissue of patients with nephrogenic systemic fibrosis. J Am Acad Dermatol. 2007 Jan;56(1):21-6. Epub 2006 Nov 9. — View Citation

Khurana A, Greene JF Jr, High WA. Quantification of gadolinium in nephrogenic systemic fibrosis: re-examination of a reported cohort with analysis of clinical factors. J Am Acad Dermatol. 2008 Aug;59(2):218-24. doi: 10.1016/j.jaad.2008.04.010. Epub 2008 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine causative or associated factors for the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or related diagnosis.		1988 to present	Yes
Secondary	Tissue Gadolinium Level in 5 groups of patients, with and without NSF	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.	1988 to present	No