NCT02512796

In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gadolinium Toxicity

Interventions

Type	Name	Description
DRUG	Gadolinium contrast dye	Gadolinium contrast dye administered during MRI

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-07-31
• Last updated: 2015-07-31

Locations

1 site across 1 country: United States