Gadopiclenol in Contrast Enhanced MRI of the Prostate

Gadopiclenol (Elucirem): A New Gadolinium Based Contrast Agent With High Relaxivity for Increased Contrast and Improved Differentiation of Clinically Significant Prostate Cancer on Contrast Enhanced MRI: A Prospective Study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06226129

Enrollment

150

Registered

2024-01-26

Start date

2024-02-14

Completion date

2028-02-01

Last updated

2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

MRI, Prostate, Contrast Agent

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.

Interventions

DRUGGadopiclenol

Gadopiclenol for contrast enhanced MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactNicolas Bloch, MD

bnb2134@cumc.columbia.edu212 305 0519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026