CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Pre-operative MRI with Dotarem +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03337594
NCT03337594N/ACompleted
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Gadolinium Retention in Human Bone Tissue in Pediatric Patients: a Comparison of Dotarem Versus MultiHance MRI Contrast Agents

Donna Roberts·observational·Posted Nov 9, 2017·Updated Dec 12, 2024

In Brief

An observational study evaluating Pre-operative MRI with Dotarem, Pre-operative MRI with MultiHance, and 1 other intervention for Gadolinium and 4 related conditions. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGadolinium, MultiHance, Dotarem, Magnetic Resonance Imaging, Gadolinium Retention
CountriesUnited States
CollaboratorsNational Institute of Standards and Technology

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartOct 1, 2017
Primary CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 8.6 years ago

Interventions

Pre-operative MRI with Dotaremdrug

Dotarem® (gadoterate meglumine - Guerbet)

Pre-operative MRI with MultiHancedrug

MultiHance® (gadobenate dimeglumine - Bracco)

Surgeryprocedure

Cardiac surgery