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Gadopiclenol in Contrast Enhanced MRI of the Prostate

NCT06226129 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-17

No results posted yet for this study

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

Interventions

DRUG

Gadopiclenol

Gadopiclenol for contrast enhanced MRI

Sponsors & Collaborators

Principal Investigators

  • Nicolas Bloch, MD · Columbia University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2027-02-01
Completion
2028-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226129 on ClinicalTrials.gov