A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)

Date Added
October 26th, 2023
PRO Number
Pro00128377
Researcher
Justin Chetta

List of Studies

Keywords
Children's Health, Infant
Summary

This is a Phase I (determine the safety of a drug) study that is looking at how long the contrast agent gadoquatrane stays in the plasma (part of blood not including red cells) after a single injection during an MRI in children aged 0-18 years. Gadoquatrane is an investigational drug, which means that it is not approved by the FDA. This study will be assessing the safety of gadoquatrane for up to 8 days following the administration of gadoquatrane at the MRI. Blood samples will be collected three times within the 8 hours following the MRI for analysis of how much gadoquatrane is left in the blood.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu



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