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NCT01014754 · ClinicalTrials.gov registry record
Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 24
- Enrollment target
NCT01014754 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 24 participants.
The verdict
NCT01014754 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study 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: * 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-08 |
| Est. Completion | 2014-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01014754
The ClinicalTrials.gov registry entry for NCT01014754 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01014754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01014754 about?
NCT01014754 is a clinical study titled "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, ...
What is the current status of trial NCT01014754?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2007-08. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT01014754?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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