Study on Gadopiclenol for Enhanced MRI Scans of the Prostate

Sponsor: Columbia University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06226129

Provider View

This clinical trial is testing a new contrast agent called Gadopiclenol to see if it can improve the clarity and detail of MRI scans for detecting significant prostate cancer.

Patient Parameters

Program Overview

The main goal of this study is to find out if a new contrast agent, Gadopiclenol, can make MRI scans of the prostate clearer and more detailed. This could help doctors better identify and classify important prostate cancers using a specific MRI classification system called PI-RADS v2.

Description

Gadopiclenol is a type of contrast agent used in MRI scans. It works by improving the visibility of tissues that have more blood flow or higher density of small blood vessels, which can help highlight cancerous areas. This study aims to show that Gadopiclenol can help detect and classify significant prostate cancer more effectively than traditional MRI methods. The study will compare the results of MRI scans using Gadopiclenol with the results of prostate biopsies that are guided by MRI and ultrasound.

Eligibility Criteria

Inclusion Criteria

  • Scheduled to have an MRI of the prostate with contrast as part of your medical care.
  • Scheduled or likely to be scheduled for a prostate biopsy that combines MRI and ultrasound, with biopsy results available within 6 months of the MRI.

Exclusion Criteria

  • Currently in prison.
  • Have already started treatment for prostate cancer, such as surgery, radiation, hormone therapy, or chemotherapy.
  • Have end-stage kidney failure and are on dialysis, or have severe kidney problems that make MRI unsafe according to medical guidelines.

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