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

Completed

• Conditions: Nephrogenic Systemic Fibrosis; Nephrogenic Fibrosing Dermopathy

• Registration Number: NCT01014754
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Biopsy-confirmed diagnosis of NSF

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine causative or associated factors for the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or related diagnosis.	1988 to present

Secondary Outcome Measures

Name	Time	Method
Tissue Gadolinium Level in 5 groups of patients, with and without NSF	1988 to present	* 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.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States