Gadopiclenol in Contrast Enhanced MRI of the Prostate

Phase 4

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Gadopiclenol

• Registration Number: NCT06226129
• Lead Sponsor: University of Massachusetts, Worcester

Brief 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.

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Study Start: 2024-02-01
• Primary Completion: 2027-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadopiclenol	Gadopiclenol	Gadopiclenol in dose, route of administration, and indication that is FDA-approved.

Primary Outcome Measures

Name	Time	Method
Blinded Radiology Review of Enhancement of Images, Graded 1-5	Through Study Completion (An Average of 1 Year Post-MRI)	Single qualitative grade for contrast enhancement quality, with each exam being graded on a scale of 1-(Fail) to 5-(Excellent) contrast enhancement quality.

Secondary Outcome Measures

Name	Time	Method
Quantitative Measurements of Wash-In/Wash-Out Contrast Curve	Through Study Completion (An Average of 1 Year Post-MRI)	The secondary outcomes will be the quantitative measurement of the wash-in/wash-out contrast curve of the individual PI-RADS lesions.

Trial Locations

Locations (1)

UMass Medical School; 🇺🇸 Worcester, Massachusetts, United States