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

NCT06406517 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-05-09

No results posted yet for this study

Summary

The goal of this clinical trial is to learn how well and at what doses gadopiclenol, a new intravenous (IV) contrast agent used for MRI, works to produce high-quality MRI images of the heart, in patients with a history of congenital heart disease, when compared to gadobenate dimeglumine, the IV contrast agent that is normally used at our institution for heart (cardiac) MRI. The main questions it aims to answer are:

* Does using gadopiclenol result in similar or superior image quality, similar signal-to-noise ratio (SNR), and similar flow measurements with 4-dimensional (4D) flow cardiac MRI when compared to gadobenate dimeglumine?
* At what dose(s) does gadopiclenol result in similar image quality (using the above metrics) for cardiac MRI when compared to gadobenate dimeglumine?

Researchers will compare cardiac MRI images obtained after administration of gadopiclenol to cardiac MRI images obtained after administration of gadobenate dimeglumine (called the standard of care treatment) to see if the images are of similar or superior quality.

Participants will:

* Be randomized to receive either gadopiclenol at one of three different doses or gadobenate dimeglumine before their congenital heart cardiac MRI
* Undergo their congenital heart cardiac MRI as they would during the course of normal clinical care.

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.

Sponsors & Collaborators

Principal Investigators

  • Albert Hsiao, MD/PhD · Department of Radiology, UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06406517 on ClinicalTrials.gov