Gadopiclenol for Prostate Cancer

Recruiting at 1 trial location

Overseen By Nicolas Bloch, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Columbia University

Disqualifiers: Prostate cancer treatment, Renal failure, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new contrast agent, Gadopiclenol, to determine if it improves the clarity of prostate MRIs. The goal is to help doctors better identify significant prostate cancer cases using MRI scans. Participants should already be scheduled for a prostate MRI and likely a biopsy (a sample of tissue for testing) within six months. This trial excludes those who have already started prostate cancer treatments like surgery or chemotherapy. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Gadopiclenol?

Research has shown that Gadopiclenol, the treatment under study, is safe. In a safety review of 1,047 participants, most did not experience serious side effects, indicating that Gadopiclenol is well-tolerated. Another study compared it to a similar contrast agent and found it just as safe, even at a lower dose. Furthermore, after its first year on the market, additional safety data confirmed its good safety record. This evidence suggests that Gadopiclenol is safe for use in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Gadopiclenol is unique because it offers a novel approach to imaging in prostate cancer. Unlike traditional MRI contrast agents, gadopiclenol provides enhanced imaging quality, which can lead to more accurate detection and characterization of prostate tumors. Researchers are excited about this treatment because it has the potential to improve diagnostic precision, allowing for better-targeted therapies and potentially improved patient outcomes. Its FDA-approved formulation and administration route also make it a promising addition to current diagnostic tools.

What evidence suggests that Gadopiclenol is effective for prostate cancer?

Research has shown that Gadopiclenol, which participants in this trial will receive, effectively improves MRI images, particularly for prostate cancer. It provides clearer images than some other agents, making it easier to detect and understand significant prostate cancer. Studies have found that Gadopiclenol's ability to enhance image contrast aids in better identifying problem areas on MRIs. The FDA has already approved this contrast agent for certain uses, demonstrating its effectiveness and safety in medical imaging. ^{1 2 4 6 7}

Who Is on the Research Team?

Nicolas Bloch, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer who are candidates for MRI. Specific eligibility criteria aren't provided, but typically participants must be in good health aside from their prostate cancer and able to undergo an MRI.

Inclusion Criteria

I am scheduled for a prostate biopsy soon, or it's very likely I will be.

I am scheduled for a contrast MRI of my prostate.

Exclusion Criteria

I have started treatment for prostate cancer, including surgery, radiotherapy, hormone therapy, or chemotherapy.

I am on dialysis for end-stage kidney failure.

I do not have chronic or acute kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Gadopiclenol for contrast-enhanced MRI to facilitate detection and classification of prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Gadopiclenol

Trial Overview The study is testing Gadopiclenol (Elucirem), a new contrast agent used during an MRI of the prostate. The goal is to see if it provides clearer images that help distinguish aggressive prostate cancer using PI-RADS v2 categories.

How Is the Trial Designed?

Group I: Gadopiclenol Experimental Treatment 1 Intervention

Gadopiclenol in dose, route of administration, and indication that is FDA-approved.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Guerbet

Industry 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06226129?aggFilters=phase%3A4+3%2CstudyType%3Aint

Gadopiclenol in Contrast Enhanced MRI of the Prostate In this study, the objective is to demonstrate that Gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, ...

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

A New Contrast Agent for MRI of the CNS and Body The results from the phase IIb study indicated that gadopiclenol at a dose of 0.1 mmol/kg provides significantly higher contrast enhancement of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633221003676

Effectiveness of Dynamic Contrast Enhanced MRI with a ... Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI.

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

Efficacy and Safety of Half-Dose Gadopiclenol versus Full- ... Gadopiclenol offers a substantially higher relaxivity than current state-of-the-art GBCAs (16). Accordingly, gadopiclenol could be used at a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10876744/

The role of gadolinium-based contrast agents in magnetic ... This overview suggests that GBCA are today required in most of the current RADS and are expected to be used in most MRIs performed in patients with cancer.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39692431/

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 ...