Gadolinium Retention in Human Bone Tissue in Pediatric Patients

Donna Roberts57 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gadolinium MultiHance Dotarem Magnetic Resonance Imaging Gadolinium Retention

Interventions

Pre-operative MRI with DotaremDRUG

Dotarem® (gadoterate meglumine - Guerbet)

Pre-operative MRI with MultiHanceDRUG

MultiHance® (gadobenate dimeglumine - Bracco)

SurgeryPROCEDURE

Cardiac surgery

Eligibility

Sex: ALLMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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: 1. Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes. 2. Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes. 3. Patients who have not been exposed to gadolinium-based contrast agent administration Exclusion Criteria: * 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).

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

To determine the gadolinium concentration present in bone tissue in pediatric patients following a standard of care MRI with MultiHance, Dotarem, or without any exposure to contrast.

To determine the gadolinium concentration present in sternum and rib bone tissue in 2 groups of pediatric patients requiring cardiac surgery as part of their standard clinical treatment: (1) patients who had undergone the administration of a standard clinical dose of a linear GBCA (0.1 mmol/kg IV MultiHance), and (2) patients who had undergone the administration of a standard clinical dose of a macrocyclic GBCA (0.1 mmol/kg IV Dotarem). As a control, gadolinium concentration present in sternum bone tissue will also be determined in patients who had not been exposed to GBCA administration prior to surgery.

Time frame: July 2017 to October 2022

Secondary Outcomes

Asses the number of exposures to contrast agent as a potential confounder.

Number of exposures to contrast agent is a potential confounder. Thus we will perform linear regression, with concentration as the outcome, and both type of contrast agent (i.e. group) and number of doses as independent variables. Although the sample size is small, we may consider evaluating an interaction between type of contrast and number of doses as an exploratory analysis.

Time frame: July 2017 to October 2022

Data from ClinicalTrials.gov

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