Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIH Grant #2 R01 CA102713-03A2 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Gadolinium Level in 5 groups of patients, with and without NSF |
|
Not provided
NSF group
Inclusion Criteria:
Exclusion Criteria:
Normal renal plus gadolinium exposure
Inclusion Criteria:
Exclusion Criteria:
Abnormal renal plus gadolinium exposure
Inclusion Criteria:
Exclusion Criteria:
Abnormal renal without gadolinium exposure
Inclusion Criteria:
Exclusion Criteria:
Normal renal without gadolinium exposure
Inclusion Criteria:
Exclusion Criteria:
Controls (neonatal)
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Laumann, MBChB, MRCP(UK) | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17097388 | Background | 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. | |
| 18538448 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054989 | Nephrogenic Fibrosing Dermopathy |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Existing skin tissue from standard of care biopsies
| 1988 to present |
| 11041404 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |