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In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02512796
Enrollment
60
Registered
2015-07-31
Start date
2015-07-31
Completion date
2017-12-31
Last updated
2015-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gadolinium Toxicity

Keywords

Liver transplantation, Renal transplantation, Pancreas transplantation

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.

Interventions

DRUGGadolinium contrast dye

Gadolinium contrast dye administered during MRI

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
total number of circulating fibrocytes2-4 weeks2-4 weeks after gadolinium contrast exposure

Countries

United States

Contacts

Primary ContactSundararaman Swaminathan, MD
ss4sa@virginia.edu434-982-3577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026