Gadopiclenol in Contrast Enhanced MRI of the Prostate
Status
RECRUITING
Phase
PHASE4
Age
≥ 18 Years
Enrollments
150Conditions
Prostate CancerDrugs
GadopiclenolSummary
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.
Detailed 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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Nicolas Bloch, MD
Principal Investigator
- Nicolas Bloch, MD
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.
Study Plan
Gadopiclenol
EXPERIMENTAL
Gadopiclenol in dose, route of administration, and indication that is FDA-approved.
DRUG:
GadopiclenolDescription:
Gadopiclenol for contrast enhanced MRI
Outcome Measures
Primary Outcome Measures
Blinded Radiology Review of Enhancement of Images, Graded 1-5
Secondary Outcome Measures
Quantitative Measurements of Wash-In/Wash-Out Contrast Curve
Timeline
Last Updated
October 17, 2025Start Date
January 26, 2024Today
March 13, 2026Completion Date ( Estimated )
February 1, 2028
Sponsors of this trial
Lead Sponsor
Columbia UniversityCollaborating Sponsors
Guerbet
RECRUITING 
18 - 80 Years