NCT06226129 · Columbia University
Gadopiclenol in Contrast Enhanced MRI of the Prostate
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Gadopiclenol
Gadopiclenol for contrast enhanced MRI
Primary outcome measures
Blinded Radiology Review of Enhancement of Images, Graded 1-5
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- New York, New York
Collaborators
Guerbet
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations