Gadopiclenol for Stenosis

Not yet recruiting at 40 trial locations

Overseen By Frantz Hébert, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Guerbet

Must not be taking: Contrast agents

Disqualifiers: Pregnancy, Severe renal impairment, 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: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two MRI contrast agents, gadopiclenol and gadoterate meglumine, to determine which better aids doctors in diagnosing artery diseases. Individuals who have experienced issues such as a prior stroke, sudden vision loss, leg pain while walking, or high blood pressure unresponsive to medication might be suitable for this study. Participants will receive both contrast agents at different times to assess their effectiveness in imaging. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to advancements in medical diagnostics.

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

Research has shown that gadopiclenol is generally safe. In a study with 1,047 participants, it was well-tolerated, and further safety checks after market release confirmed these positive results. This indicates that both in studies and real-world use, gadopiclenol has demonstrated safety.

For gadoterate meglumine, years of safety data show that side effects are rare, with only about 8 out of 100,000 patients experiencing issues. However, serious reactions can occur if used incorrectly, such as in the spine.

Both gadopiclenol and gadoterate meglumine have been researched and used, demonstrating general safety for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about gadopiclenol for treating stenosis because it may offer clearer imaging results compared to current contrast agents like gadoterate meglumine. Unlike standard options, gadopiclenol is designed to provide enhanced image clarity at potentially lower doses, reducing the risk of side effects. This could lead to more accurate diagnosis and management of stenosis, making it a promising option for both doctors and patients.

What evidence suggests that this trial's treatments could be effective for vascular diseases?

This trial will compare the effectiveness of Gadopiclenol and Gadoterate meglumine in MRI scans. Research has shown that Gadopiclenol, which participants in this trial may receive, provides clear images of lesions similar to well-known contrast agents, even at half the usual dose, making it promising for body imaging. Gadoterate meglumine, another treatment option in this trial, boosts confidence in diagnosing conditions from images and generally produces high-quality MRI images. Both agents have strong safety records, making them reliable choices for improving MRI images. These findings support their potential effectiveness in diagnosing vascular diseases using MRI. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with suspected vascular disease, who have experienced symptoms like prior stroke or severe hypertension, and are scheduled for imaging tests. They must consent to follow the study procedures and sign an informed consent form.

Inclusion Criteria

I am 18 or older and willing to follow the study's procedures.

I have read, understood, and signed the consent form for this trial.

I am scheduled for or have had imaging tests for arteries in my neck, limbs, or abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gadopiclenol or gadoterate meglumine for MRA to assess steno-occlusive disease

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gadopiclenol
• Gadoterate meglumine

Trial Overview

The trial is testing two contrast agents used in MRI scans: gadopiclenol and Gadoterate meglumine (Dotarem), to see which one better assesses steno-occlusive disease in arteries above the heart, as well as peripheral or abdominal/renal arteries.

How Is the Trial Designed?

Group I: AB Experimental Treatment 2 Interventions

Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg

Group II: BA Active Control 2 Interventions

Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol

Who Is Running the Clinical Trial?

Guerbet

Lead Sponsor

Trials

72

Recruited

94,600+

David Hale

Guerbet

Chief Executive Officer since 2020

MBA from IMD

Philippe Bourrinet

Guerbet

Chief Medical Officer since 2023

MD

Bracco Imaging S.p.A.

Industry Sponsor

Trials

6

Recruited

930+

Citations

1.

bracco.com

bracco.com/en-us/article/data-reinforcing-efficacy-and-safety-gadopiclenol-contrast-enhanced-mri-certain-body-0

Data Reinforcing Efficacy and Safety of Gadopiclenol in ...

The results of the multicenter, international PROMISE clinical trial demonstrate that gadopiclenol provides similar lesion visualization and ...

2.

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 ...

3.

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.

4.

prnewswire.com

prnewswire.com/news-releases/data-reinforcing-efficacy-and-safety-of-gadopiclenol-in-contrast-enhanced-mri-of-certain-body-regions-published-in-radiology-301881361.html

Data Reinforcing Efficacy and Safety of Gadopiclenol in ...

The results of the multicenter, international PROMISE clinical trial demonstrate that gadopiclenol provides similar lesion visualization and ...

5.

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

Data from large-scale, preapproval clinical studies revealed a favorable safety profile and noninferior efficacy for 0.05 mmol/kg gadopiclenol when compared ...

6.

bracco.com

bracco.com/en-us/article/data-reinforcing-efficacy-and-safety-gadopiclenol-contrast-enhanced-mri-certain-body

Data Reinforcing Efficacy and Safety of Gadopiclenol in ...

Gadopiclenol is highly stable and shows the highest relaxivity among the gadolinium-based contrast agents available for clinical use. ii, ììì, ...

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 ...