NCT03337594

Gadolinium Retention in Human Bone Tissue in Pediatric Patients

Gadolinium Retention in Human Bone Tissue in Pediatric Patients: a Comparison of Dotarem Versus MultiHance MRI Contrast Agents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Donna Roberts · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 patients. The patients receiving contrast will then be compared against pediatric patients who have not received any contrast prior to cardiac surgeries.

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 gadolinium based contrast agents (GBCAs) are widely used in medical imaging. Recently, new evidence suggests that following GBCA administration, gadolinium can be deposited in body tissues even in the presence of normal renal function. Therefore, it is essential to ensure that significant accumulation of free Gd3+ is not occurring in the bones of children undergoing clinical contrasted MRI scans. This is particularly important for those pediatric patients who will undergo multiple repeated MRI exams throughout their lifetime and thereby be exposed to a large cumulative dose of gadolinium contrast. As the differences in stability between the various GBCAs may be a factor in gadolinium exposure, the primary objective of this study is to assess gadolinium deposition in the bones of pediatric patients in two patient groups: 1. patients who received IV administration of gadolinium contrast agent (Dotarem) and 2. patients who received IV administration of gadolinium contrast agent (MultiHance). Once acquired the samples will be analyzed at an off-site facility, National Institute of Standards and Technology (NIST), using standardized equipment which has been certified for measuring gadolinium concentration in contrast agent samples. A signed agreement for the transfer of non-proprietary biological material between MUSC and NIST covers the transfer of the samples.

Conditions

• Gadolinium
• MultiHance
• Dotarem
• Magnetic Resonance Imaging
• Gadolinium Retention

Interventions

Type	Name	Description
DRUG	Pre-operative MRI with Dotarem	Dotarem® (gadoterate meglumine - Guerbet)
DRUG	Pre-operative MRI with MultiHance	MultiHance® (gadobenate dimeglumine - Bracco)
PROCEDURE	Surgery	Cardiac surgery

Timeline

• Start date: 2017-10-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2017-11-09
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study