Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI: Phase II Clinical Trial

Date Added
December 14th, 2021
PRO Number
Pro00116913
Researcher
Donna Roberts

List of Studies


Keywords
Children's Health, Infant
Summary

This is a Phase II (determine the safety and response of a drug) study that is looking at how long the contrast agent Gadopiclenol stays in the plasma (part of blood not including red cells) after a single injection during an MRI in children aged up to and including 23 months. Gadopiclenol is an investigational drug, which means that it is not approved by the FDA. This study will be assessing the safety of gadopiclenol for up to 3 months following the administration of gadopiclenol at the MRI, and will evaluate the quality of the images obtained from when gadopiclenol was used at the MRI. Blood samples will be collected three times within the 8 hours following the MRI for analysis of how much gadopiclenol is left in the blood.

Institution
MUSC
Recruitment Contact
Elise Zhao
843-792-2354
zhaoel@musc.edu



-- OR --