Gadolinium Retention in Human Bone Tissue in Pediatric Patients

May 11, 2023 updated by: Donna Roberts

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Donna R Roberts, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All subjects, newborn to 18 years, scheduled for a prospective clinically indicated, contrast-enhanced, cardiac MRI will potentially be eligible for inclusion into the study. Potential subjects will be identified via pediatric cardiology, pediatric cardiothoracic surgery, or clinical schedules and consultation with attending physicians according to satisfaction of the inclusion and exclusion criteria listed above.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Pediatric patients who have not been exposed to gadolinium-based contrast agent administration and who require cardiac surgery as part of their standard clinical treatment.
Procedure: Surgery
Cardiac surgery
Dotarem
Pediatric patients who have undergone routine contrast-enhanced MRI using only Dotarem contrast agent for clinical purposes and who require cardiac surgery as part of their standard clinical treatment.
Procedure: Surgery
Cardiac surgery
Drug: Pre-operative MRI with Dotarem
Dotarem® (gadoterate meglumine - Guerbet)
Other Names:
  • gadoterate meglumine
MultiHance
Pediatric patients who have undergone routine contrast-enhanced MRI using only MultiHance contrast agent for clinical purposes and who require cardiac surgery as part of their standard clinical treatment.
Procedure: Surgery
Cardiac surgery
Drug: Pre-operative MRI with MultiHance
MultiHance® (gadobenate dimeglumine - Bracco)
Other Names:
  • gadobenate dimeglumine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
July 2017 to October 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
July 2017 to October 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Donna Roberts

Collaborators

National Institute of Standards and Technology

Investigators

  • Principal Investigator: Donna R Roberts, M.D., Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00048639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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