Gadopiclenol in Contrast Enhanced MRI of the Prostate

Paused · Phase 4

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06226129

Run by

Columbia University

People needed

150

Starts

2024-02-14

Expected to finish

2028-02-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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