Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels
Study Details
Study Description
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:
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Those affected by NSF.
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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.
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Those with normal kidney function who have never been exposed to GBCA and have had a skin biopsy.
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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.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| NSF Biopsy-proven diagnosis of NSF |
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| Kidney dysfunction plus gadolinium exposure 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. |
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| Kidney dysfunction without gadolinium exposure Those on dialysis or with eGFR ≤ 30 ml/min/1.73 m2 who have never been exposed to GBCA and have had skin biopsy. |
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| Normal kidney function with gadolinium exposure 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. |
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| Normal kidneys without gadolinium exposure Those with normal kidney function who have never been exposed to GBCA and have had a skin biopsy. |
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| Controls Existing skin tissue from neonatal skin (<6 months) will be used as controls, as they presumably have never been exposed to gadolinium |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
NSF group
Inclusion Criteria:
- Biopsy-confirmed diagnosis of NSF
Exclusion Criteria:
- Does not have NSF
Normal renal plus gadolinium exposure
Inclusion Criteria:
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eGFR >30
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Existing skin tissue sample
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Gadolinium exposure in 2 years preceding skin biopsy
Exclusion Criteria:
- Does not fit inclusion criteria
Abnormal renal plus gadolinium exposure
Inclusion Criteria:
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eGFR <30 or on dialysis
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Existing skin tissue sample
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Gadolinium exposure in 2 years preceding skin biopsy
Exclusion Criteria:
- Does not fit inclusion criteria
Abnormal renal without gadolinium exposure
Inclusion Criteria:
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eGFR <30 or on dialysis
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Existing skin tissue sample
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No gadolinium exposure ever
Exclusion Criteria:
- Does not fit inclusion criteria
Normal renal without gadolinium exposure
Inclusion Criteria:
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eGFR >30
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Existing skin tissue sample
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Anne Laumann, MBChB, MRCP(UK), Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- STU1460
- NIH Grant #2 R01 CA102713-03A2