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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Nicolas Bloch, MD
bnb2134@cumc.columbia.edu
212 305 0519
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 150
Treatments
Experimental: Gadopiclenol
Gadopiclenol in dose, route of administration, and indication that is FDA-approved.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Guerbet