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Completed

NCT Number: NCT03337594

Gadolinium Retention in Human Bone Tissue in Pediatric Patients

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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).

Treatment and study plan

Pre-operative MRI with Dotarem

Drug

Dotarem® (gadoterate meglumine - Guerbet)

Other names: gadoterate meglumine

Pre-operative MRI with MultiHance

Drug

MultiHance® (gadobenate dimeglumine - Bracco)

Other names: gadobenate dimeglumine

Surgery

Procedure

Cardiac surgery

Primary outcomes

  1. 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.

    Time frame: July 2017 to October 2022

    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.

Secondary outcomes

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

    Time frame: July 2017 to October 2022

    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.

Sponsors and collaborators

Lead sponsor

Donna Roberts

Other

Collaborators

  • National Institute of Standards and Technology

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2017
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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