Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

May 31, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Congenital Heart Disease
Interventions
DRUG

Gadopiclenol

Gadopiclenol is an FDA-approved gadolinium-based contrast agent (GBCA) for neurological and abdominal contrast-enhanced MRI. Participants will receive this contrast agent at one of three different doses prior to undergoing a congenital heart cardiac MRI/MRA. This contrast agent will be compared to gadobenate dimeglumine, the standard-of-care.

DRUG

Gadobenate dimeglumine

Gadobenate dimeglumine is an FDA-approved GBCA that is used in standard clinical practice at UCSD for contrast-enhanced MRI/MRA studies, including cardiac MRI/MRA. This contrast agent is the standard of care to which gadopiclenol will be compared.

Trial Locations (1)

92037

University of California San Diego Health, San Diego

All Listed Sponsors
collaborator

Bracco Imaging S.p.A.

INDUSTRY

lead

University of California, San Diego

OTHER

NCT06406517 - Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics | Biotech Hunter | Biotech Hunter