Overview
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Status:
Completed
Completed
Trial end date:
2020-12-09
2020-12-09
Target enrollment:
0
0
Participant gender:
All
All
Summary
The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Guerbet
Criteria
Inclusion Criteria:- Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s)
in at least one body region based on a previous imaging procedure performed within 12
months prior to ICF signature. US patients are restricted to the breast in compliance
with local approved indications of gadobutrol.
Exclusion Criteria:
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated
Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to
each contrast agent administration.