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.
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 prostate-cancer
Started Feb 2024
Typical duration for phase_4 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
October 20, 2025
October 1, 2025
3 years
January 2, 2024
October 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blinded Radiology Review of Enhancement of Images, Graded 1-5
Single qualitative grade for contrast enhancement quality, with each exam being graded on a scale of 1-(Fail) to 5-(Excellent) contrast enhancement quality.
Through Study Completion (An Average of 1 Year Post-MRI)
Secondary Outcomes (1)
Quantitative Measurements of Wash-In/Wash-Out Contrast Curve
Through Study Completion (An Average of 1 Year Post-MRI)
Study Arms (1)
Gadopiclenol
EXPERIMENTALGadopiclenol in dose, route of administration, and indication that is FDA-approved.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Guerbetcollaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Bloch, MD
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 26, 2024
Study Start
February 14, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share