Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels
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Purpose
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.
| Condition |
|---|
|
Nephrogenic Systemic Fibrosis Nephrogenic Fibrosing Dermopathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control |
| Official 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Tissue Gadolinium Level in 5 groups of patients, with and without NSF [ Time Frame: 1988 to present ] [ Designated as safety issue: No ]
- 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.
Biospecimen Retention: Samples With DNA
Existing skin tissue from standard of care biopsies
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
NSF
Biopsy-proven diagnosis of NSF
|
|
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.
|
|
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.
|
|
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.
|
|
Normal kidneys without gadolinium exposure
Those with normal kidney function who have never been exposed to GBCA and have had a skin biopsy.
|
|
Controls
Existing skin tissue from neonatal skin (<6 months) will be used as controls, as they presumably have never been exposed to gadolinium
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Those with NSF (25). 40 subjects selected through Northwestern University Department of Dermatology's existing medical records and pathology specimens. Medical records will be reviewed to identify 10 subjects who have had a standard of care skin biopsy in the dermatology clinics at Northwestern University and who were exposed to Gadolinium in the 2 years prior to skin biopsy. Another 10 subjects who have had skin biopsy and who have never been exposed to GBCA during a medical imaging procedure will also be identified. Another 10 subjects on dialysis or with eGFR ≤30 exposed to GBCA in the 2 years prior to skin biopsy will be identified. Another group of 10 subjects on dialysis or with eGFR ≤30 who have had skin biopsy and who have never been exposed to GBCA during a medical imaging procedure will also be identified. Neonatal skin tissue of up to 10 subjects with existing skin tissue sample will be sent for analysis.
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
Contacts and Locations| United States, Illinois | |
| Northwestern University Feinberg School of Medicine, Department of Dermatology | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Anne Laumann, MBChB, MRCP(UK) | Northwestern University |
More Information
Publications:
| Responsible Party: | Anne Laumann, Professor of Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01014754 History of Changes |
| Other Study ID Numbers: | STU1460, NIH Grant #2 R01 CA102713-03A2 |
| Study First Received: | November 13, 2009 |
| Last Updated: | April 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fibrosis Nephrogenic Fibrosing Dermopathy Pathologic Processes Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013