Actively Recruiting

Phase 4
Age: 18Years +
MALE
NCT06226129

Gadopiclenol in Contrast Enhanced MRI of the Prostate

Led by Columbia University · Updated on 2025-10-20

150

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

G

Guerbet

Collaborating Sponsor

AI-Summary

What this Trial Is About

The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories.

CONDITIONS

Official Title

Gadopiclenol in Contrast Enhanced MRI of the Prostate

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled to undergo a clinically indicated MRI of the prostate with contrast.
  • Scheduled to undergo, or likely to be scheduled to undergo, a prostate MRI-US fusion biopsy with histology results available within 6 months of their MRI.
Not Eligible

You will not qualify if you...

  • Prisoner
  • Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.
  • Patients with end stage renal failure who are on dialysis.
  • Patients with chronic kidney disease or acute kidney injury contraindicated for MRI per FDA and ACR guidelines.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

N

Nicolas Bloch, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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