Gadopiclenol in Contrast Enhanced MRI of the Prostate

Sponsor: Columbia University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06226129

Patient View

This study evaluates Gadopiclenol's efficacy in enhancing prostate MRI contrast to improve detection and classification of significant prostate cancer, using MRI-US fusion biopsy results. Eligible participants are those scheduled for prostate MRI with contrast and potential MRI-US fusion biopsy. The intervention involves using Gadopiclenol as a contrast agent.

Patient Parameters

Program Overview

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.

Description

Gadolinium based contrast agents with higher relaxivity have been shown to improve contrast enhancement and differentiation of tissues with increased blood perfusion or with higher microvascular density (MVD), and therefore increase visibility of cancerous tissue. In this study, the objective is to demonstrate that Gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, compared to T2-W (T2 weighted image) and diffusion weighted imaging (DWI), using the detailed location-specific (individual biopsy core for each annotated target) results of subsequently performed MRI-US fusion biopsies.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

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