In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

Study Overview
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Brief Summary
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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
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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.

Official Title
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In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

Conditions
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Gadolinium Toxicity

Intervention / Treatment
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* Drug: Gadolinium contrast dye


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, Renal transplantation, Pancreas transplantation