RecruitingPhase 4NCT06226129

Gadopiclenol in Contrast Enhanced MRI of the Prostate

Gadopiclenol (Elucirem): A New Gadolinium Based Contrast Agent With High Relaxivity for Increased Contrast and Improved Differentiation of Clinically Significant Prostate Cancer on Contrast Enhanced MRI: A Prospective Study.


Sponsor

Columbia University

Enrollment

150 participants

Start Date

Feb 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a newer MRI contrast dye called gadopiclenol to see how well it works for imaging the prostate. Contrast dyes help doctors see the prostate more clearly on MRI scans. **You may be eligible if...** - You are already scheduled for a prostate MRI with contrast as part of your regular medical care - You are expected to undergo a prostate biopsy (using MRI and ultrasound guidance) within 6 months of your scan **You may NOT be eligible if...** - You are already receiving treatment for prostate cancer (such as surgery, radiation, hormone therapy, or chemotherapy) - You have severe kidney failure or are on dialysis - You have chronic kidney disease or acute kidney injury Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGadopiclenol

Gadopiclenol for contrast enhanced MRI


Locations(1)

Columbia University Medical Center

New York, New York, United States

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NCT06226129


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