In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

University of Virginia

Status: Unknown

Conditions: Gadolinium Toxicity

Treatments: Drug: Gadolinium contrast dye

Study type: Observational

Funder types: Other

Identifiers

NCT02512796

18302

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Transplant patients, MRI with Gadolinium contrast dye

Description:

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

Treatment:

Drug: Gadolinium contrast dye

Non-transplant patients, MRI with Gadolinium contrast dye

Description:

Non-transplant patients exposed to gadolinium contrast.

Treatment:

Drug: Gadolinium contrast dye

Healthy controls, no transplant no Gadolinium contrast dye

Description:

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