Status:
COMPLETED
Gadolinium Retention in Human Bone Tissue in Pediatric Patients
Lead Sponsor:
Donna Roberts
Collaborating Sponsors:
National Institute of Standards and Technology
Conditions:
Gadolinium
MultiHance
Eligibility:
All Genders
Up to 18 years
Brief Summary
The purpose of this study is to compare contrast agents, Dotarem or MultiHance. The study will test to see how much of these two contrast agents are deposited in the bones or tissues of pediatric pati...
Detailed Description
When injected into the body, gadolinium contrast medium makes certain tissues, abnormalities or disease processes more clearly visible on a magnetic resonance imaging (MRI) scans and therefore gadolin...
Eligibility Criteria
Inclusion
- Female or male pediatric patient (patients aged newborn to 18 years old at the time of the MRI scan).
- Patients who require cardiac surgery for clinical purposes and meet one of the following three criteria:
- Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes.
- Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes.
- Patients who have not been exposed to gadolinium-based contrast agent administration
Exclusion
- Patient with abnormal renal function (defined as eGFR MDRD\<30 ml/min/1.73m2).
- Patient previously exposed to any other type of MRI gadolinium based contrast agent either at MUSC or at an outside facility
- Pregnant or breast feeding female patient
- Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to standard practice at MUSC).
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03337594
Start Date
October 1 2017
End Date
August 31 2024
Last Update
December 12 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425