Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT03337594
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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Notify MeUp to 18 year
All sexes
Observational
Charleston, South Carolina, 29425, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dotarem® (gadoterate meglumine - Guerbet)
Other names: gadoterate meglumine
MultiHance® (gadobenate dimeglumine - Bracco)
Other names: gadobenate dimeglumine
Cardiac surgery
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.
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.
Donna Roberts
Other
Gadolinium Retention in Human Bone Tissue in Pediatric Patients: a Comparison of Dotarem Versus MultiHance MRI Contrast Agents
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