Gadopiclenol in Contrast Enhanced MRI of the Prostate
Recruiting
Phase 4
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 150 (estimated)
- Sponsor
- Columbia University · Other
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About This Trial
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 Locations
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Eligibility Criteria
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 a…
Contacts