In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

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

Study Overview

• Status: Unknown
• Conditions: Gadolinium Toxicity
• Intervention / Treatment: Drug: Gadolinium contrast dye

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Gadolinium exposed patients. We will use age- and sex-matched controls with and without organ transplants and not exposed to gadolinium contrast agents (within the last 3 years) as controls.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transplant patients, MRI with Gadolinium contrast dye; Patients with kidney, pancreas or liver transplant and exposed to gadolinium contrast agents.	Drug: Gadolinium contrast dye; Gadolinium contrast dye administered during MRI
Non-transplant patients, MRI with Gadolinium contrast dye; Non-transplant patients exposed to gadolinium contrast.	Drug: Gadolinium contrast dye; Gadolinium contrast dye administered during MRI
Healthy controls, no transplant no Gadolinium contrast dye; Age- and sex-matched healthy controls not exposed to gadolinium contrast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total number of circulating fibrocytes	2-4 weeks after gadolinium contrast exposure	2-4 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Sundararaman Swaminathan, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Liver transplantation; Renal transplantation; Pancreas transplantation
• Other Study ID Numbers: 18302