Gadopiclenol in Contrast Enhanced MRI of the Prostate

NCT06226129 | Suspended Phase 4 DMC FDA Drug

• 1 other identifier: AAAV5623
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

MRI; Prostate; Contrast Agent

Outcome Measures

Primary Outcomes (1)

• Blinded Radiology Review of Enhancement of Images, Graded 1-5

  Single qualitative grade for contrast enhancement quality, with each exam being graded on a scale of 1-(Fail) to 5-(Excellent) contrast enhancement quality.

  Through Study Completion (An Average of 1 Year Post-MRI)

Secondary Outcomes (1)

• Quantitative Measurements of Wash-In/Wash-Out Contrast Curve

  Through Study Completion (An Average of 1 Year Post-MRI)

Study Arms (1)

Gadopiclenol

EXPERIMENTAL

Patients who are scheduled for clinical care MRI Prostate scans with Gadopiclenol. Gadopiclenol is FDA-approved for this indication. Gadopiclenol for contrast enhanced MRI - recommended dose for adult is 0.05 mmol/kg actual body weight. The dose is the weight-based dosage regime that is indicated on the package insert.

Drug: Gadopiclenol

Interventions

Gadopiclenol DRUG

Gadopiclenol for contrast enhanced MRI

Gadopiclenol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 who have chronic kidney disease or acute kidney injury are contraindicated for MRI per FDA and ACR (American College of Radiologists) guidelines and would thus be excluded as well.

Sponsors & Collaborators

• Columbia University: lead
• Guerbet: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gadopiclenol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nicolas Bloch, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 26, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)