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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01014754

Acronym

NSF

Enrollment

Registered

2009-11-17

Start date

2007-08-31

Completion date

2014-06-30

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrogenic Fibrosing Dermopathy, Nephrogenic Systemic Fibrosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results