Completed

NCT Number: NCT01014754

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.

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Key information

Conditions

Nephrogenic Systemic Fibrosis Fibrosis Nephrogenic Fibrosing Dermopathy Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To determine causative or associated factors for the development of Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), or related diagnosis.

Time frame: 1988 to present

Secondary outcomes

Tissue Gadolinium Level in 5 groups of patients, with and without NSF

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study 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

Acronym: NSF

Important dates

Study start: 2007
Primary completion: 2014
Study completion: 2014
First posted: Nov 17, 2009
Registry last updated: Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed