Recruiting

Gadolinium Contrast

Sponsor:

University of Virginia

Code:

NCT02512796

Conditions

Gadolinium Toxicity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Gadolinium contrast dye

Study Details

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.

Conditions

Gadolinium Toxicity

Study ID

NCT02512796

Start date

Jul, 2015

Status verified date

Jul, 2015

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Transplant patients, MRI with Gadolinium contrast dye

Patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents.

Non-transplant patients, MRI with Gadolinium contrast dye

Non-transplant patients exposed to gadolinium contrast.

Healthy controls, no transplant no Gadolinium contrast dye

Age- and sex-matched healthy controls not exposed to gadolinium contrast.

Interventions

Gadolinium contrast dye

Gadolinium contrast dye administered during MRI

Primary outcome measure

  • total number of circulating fibrocytes [ Time Frame: 2-4 weeks ]

Central Contacts and Locations

Central contacts

Sundararaman Swaminathan, MD

434-982-3577ss4sa@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

More Information

Sponsor

University of Virginia

Last update posted

Jul 31, 2015

Last verified

Jul, 2015

Keywords

  • Liver transplantation
  • Renal transplantation
  • Pancreas transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2015-07-31.