In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

• Conditions: Gadolinium Toxicity
• Interventions: Drug: Gadolinium contrast dye

• Registration Number: NCT02512796
• Lead Sponsor: University of Virginia

Brief Summary

Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known of its toxicity outside of patients with reduced renal function.

Detailed Description

Gadolinium contrast is administered to patients during MRI imaging. Recently, the investigators have observed potential gadolinium toxicity in some patients. To investigate this, the investigators propose to collect clinical data and lab data obtained as a part of clinical care. The investigators also plan to obtain 25 cc of peripheral blood at 2-4 weeks, 4-6 weeks and again at 3 months to identify unique monocyte signatures, gene polymorphisms, and to quantitate circulating fibrocytes (in fresh blood and after culture). Plan to enroll 15 patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents, 15 non-transplant patients exposed to gadolinium contrast and 30 age- and sex-matched healthy controls not exposed to gadolinium contrast.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-30
• Last Update Submitted: 2015-07-30
• Study First Posted: 2015-07-31
• Last Update Posted: 2015-07-31
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Renal, pancreas or liver transplant OR those without organ transplant OR controls
• Age 18-70
• Both gender
• Exposure to gadolinium contrast agents (no exposure in controls)
• Have had a transplant, have had a contrast dye with an MRI
• Have not had a transplant and have had a contrast dye with an MRI
• Healthy person who has not had an MRI or gadolinium for any other reason.

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Exclusion Criteria

• End stage kidney disease or Stage 5
• Previous diagnosis of Nephrogenic Systemic Fibrosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-transplant patients, MRI with Gadolinium contrast dye	Gadolinium contrast dye	Non-transplant patients exposed to gadolinium contrast.
Transplant patients, MRI with Gadolinium contrast dye	Gadolinium contrast dye	Patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents.

Primary Outcome Measures

Name	Time	Method
total number of circulating fibrocytes	2-4 weeks	2-4 weeks after gadolinium contrast exposure

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States