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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if gadopiclenol, a new contrast agent for MRIs, can produce heart images as good as or better than those made with the usual agent, gadobenate dimeglumine. Researchers seek to identify the optimal dose of gadopiclenol for clear heart images in individuals with congenital heart disease. Participants will receive either gadopiclenol at one of three doses or the usual agent before their heart MRI. Individuals with congenital heart disease who are already scheduled for a heart MRI and speak English may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the availability of a potentially superior imaging agent.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that gadopiclenol, a new contrast agent for MRI scans, is generally safe. Research involving 1,047 people found gadopiclenol to have a good safety record, with most side effects being mild. During its first year of use, ongoing safety checks confirmed these findings, demonstrating that gadopiclenol remains safe. The FDA has approved gadopiclenol for MRI scans of the brain and abdomen, further supporting its safety. For those considering joining a trial with gadopiclenol, this history suggests it is well-tolerated by most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Gadopiclenol for congenital heart disease because it offers a potentially safer and more effective imaging option compared to the standard gadobenate dimeglumine. Gadopiclenol is unique due to its stronger T1-relaxing properties, which can enhance image clarity at lower doses. This means doctors could get better images of the heart with less contrast agent, potentially reducing the risk of side effects. Additionally, the trial explores different dosages of Gadopiclenol (0.075, 0.10, and 0.15 mmol/kg) to find the most effective yet safest amount, offering more personalized imaging solutions for patients.

What evidence suggests that gadopiclenol is effective for producing high-quality MRI images in congenital heart disease?

Research has shown that gadopiclenol effectively creates clear MRI images. Studies have found that using half the usual dose of gadopiclenol provides image quality similar to a full dose of gadobutrol, another contrast agent. This suggests that even smaller amounts of gadopiclenol can be effective. Trials have also proven its effectiveness in detecting issues in the brain and other parts of the body. In this trial, participants will receive different dosages of gadopiclenol to evaluate its effectiveness in producing clear heart images in patients with congenital heart disease. Although gadopiclenol is a newer option, it appears promising for this purpose. ^{1 2 4 6 7}

Who Is on the Research Team?

Albert Hsiao, MD/PhD

Principal Investigator

Department of Radiology, UC San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06406517

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

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.222612

Efficacy and Safety of Half-Dose Gadopiclenol versus Full- ... Gadopiclenol at half the standard dose for contrast-enhanced body MRI had comparable efficacy with gadobutrol at the full standard dose.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06406517?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Bracco%20Imaging%20S.p.A.%22))&rank=1

Comparative Effectiveness of Gadopiclenol for Evaluation ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11441729/

A New Contrast Agent for MRI of the CNS and Body This review describes the pharmacokinetics, efficacy, and safety of gadopiclenol, a new macrocyclic gadolinium-based contrast agent (GBCA) recently approved by ...

5. ctv.veeva.com ctv.veeva.com/study/comparative-effectiveness-of-gadopiclenol-for-evaluation-of-adult-congenital-heart-anatomy-and-hemod

Comparative Effectiveness of Gadopiclenol for Evaluation of ... Though it has been shown to be effective in detection of central nervous system (CNS) lesions and of lesions outside the CNS, its performance in ...

6. journals.lww.com journals.lww.com/investigativeradiology/fulltext/2025/06000/safety_of_gadopiclenol_after_its_first_year_of.8.aspx

Safety of Gadopiclenol After Its First Year of Clinical Use Safety data from postmarketing surveillance of gadopiclenol further confirm its positive benefit-risk profile demonstrated in preapproval clinical studies.

7. braccomr.com braccomr.com/wp-content/uploads/2025/01/Safety-of-Gadopiclenol-After-Its-First-Year-of-Clinical-Use.pdf

Safety of Gadopiclenol After Its First Year of Clinical Use Safety data from postmarketing surveillance of gadopiclenol further confirm its positive benefit-risk profile demonstrated in preapproval clinical studies ...