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In Vitro Study of the Effect of Gadolinium Contrast on Fibrocytes

NCT ID: NCT02512796

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

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.

Conditions

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Gadolinium Toxicity

Keywords

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Liver transplantation Renal transplantation Pancreas transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Transplant patients, MRI with Gadolinium contrast dye

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

Gadolinium contrast dye

Intervention Type DRUG

Gadolinium contrast dye administered during MRI

Non-transplant patients, MRI with Gadolinium contrast dye

Non-transplant patients exposed to gadolinium contrast.

Gadolinium contrast dye

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

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Gadolinium contrast dye

Gadolinium contrast dye administered during MRI

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sundararaman Swaminathan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sundararaman Swaminathan, MD

Role: CONTACT

Phone: 434-982-3577

Email: [email protected]

Other Identifiers

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18302

Identifier Type: -

Identifier Source: org_study_id