Gadopiclenol in Contrast Enhanced MRI of the Prostate

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06226129
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gadopiclenol — DRUG
    Gadopiclenol for contrast enhanced MRI

Study Details

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.

Key Dates

Start date
Feb 14, 2024
Status verified
Oct 2025
Primary completion
Feb 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Gadopiclenol
    Gadopiclenol in dose, route of administration, and indication that is FDA-approved.

Primary Outcome Measure

Blinded Radiology Review of Enhancement of Images, Graded 1-5 [ Time Frame: Through Study Completion (An Average of 1 Year Post-MRI) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Nicolas Bloch, MD

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Columbia University Medical Center· New York, NY

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