Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels
NCT ID: NCT01014754
Last Updated: 2014-12-04
Study Results
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Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2007-08-31
2014-06-30
Brief Summary
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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
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Conditions
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Study Design
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CASE_CONTROL
Study Groups
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NSF
Biopsy-proven diagnosis of NSF
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Normal kidneys without gadolinium exposure
Those with normal kidney function who have never been exposed to GBCA and have had a skin biopsy.
No interventions assigned to this group
Controls
Existing skin tissue from neonatal skin (\<6 months) will be used as controls, as they presumably have never been exposed to gadolinium
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* eGFR \>30
* Existing skin tissue sample
* Gadolinium exposure in 2 years preceding skin biopsy
Abnormal renal plus gadolinium exposure
* eGFR \<30 or on dialysis
* Existing skin tissue sample
* Gadolinium exposure in 2 years preceding skin biopsy
Abnormal renal without gadolinium exposure
* eGFR \<30 or on dialysis
* Existing skin tissue sample
* No gadolinium exposure ever
Normal renal without gadolinium exposure
* eGFR \>30
* Existing skin tissue sample
* No gadolinium exposure ever
Controls (neonatal)
* Existing skin biopsy tissue that was performed within the first 6 months of life
Exclusion Criteria
Normal renal plus gadolinium exposure
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Northwestern University
OTHER
Responsible Party
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Anne Laumann
Professor of Dermatology
Principal Investigators
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Anne Laumann, MBChB, MRCP(UK)
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
Countries
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References
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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. doi: 10.1016/j.jaad.2006.10.047. 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.
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. doi: 10.1016/S0140-6736(00)02694-5.
Other Identifiers
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NIH Grant #2 R01 CA102713-03A2
Identifier Type: -
Identifier Source: secondary_id
STU1460
Identifier Type: -
Identifier Source: org_study_id