Gadopiclenol for Congenital Heart Disease

Overseen By Roshun Sankaran, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Diego

Disqualifiers: Pediatric, Pregnant, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on comparing two contrast agents for MRI, so it's best to ask the trial coordinators for specific guidance.

What is the purpose of this trial?

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.

Research Team

Albert Hsiao, MD/PhD

Principal Investigator

Department of Radiology, UC San Diego

Eligibility Criteria

This trial is for adults with congenital heart disease who need an MRI. Participants will be given a new IV contrast agent, gadopiclenol, or the standard one used at the research site, gadobenate dimeglumine. The study excludes specific details on eligibility criteria.

Inclusion Criteria

I have a congenital heart condition and will have a cardiac MRI and chest MRA.

English is patient's primary spoken language

Exclusion Criteria

I do not have severe kidney problems (GFR above 30).

Pregnant patients

History of hypersensitivity reaction to gadolinium based contrast agent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either gadopiclenol at one of three different doses or gadobenate dimeglumine before their congenital heart cardiac MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for image quality, signal-to-noise ratio, and standard deviation of volumetric flow measurements

4 weeks

Treatment Details

Interventions

• Gadopiclenol

Trial Overview Researchers are testing if gadopiclenol can produce better or equal quality MRI images compared to the standard contrast agent. They're looking at image clarity and flow measurements in different doses of gadopiclenol versus the usual treatment.

Participant Groups

Group I: Gadopiclenol 0.15 mmol/kg Experimental Treatment 1 Intervention

Group II: Gadopiclenol 0.10 mmol/kg Experimental Treatment 1 Intervention

Group III: Gadopiclenol 0.075 mmol/kg Experimental Treatment 1 Intervention

Group IV: Gadobenate dimeglumine 0.15 mmol/kg (standard of care) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Bracco Imaging S.p.A.

Industry Sponsor

Trials

6

Recruited

930+