Gadopiclenol-enhanced MRI for prostate cancer
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.
PHASE4 · Columbia University · NCT06226129
This trial will test whether the new contrast agent gadopiclenol helps prostate MRI show clinically significant prostate cancer more clearly for men scheduled for prostate MRI and MRI-US fusion biopsy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Columbia University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06226129 on ClinicalTrials.gov |
What this trial studies
Gadopiclenol is a high-relaxivity gadolinium contrast agent given during prostate MRI to increase contrast enhancement. In this single-center Phase 4 trial at Columbia University, participants scheduled for clinically indicated contrast MRI and MRI-US fusion biopsy receive gadopiclenol-enhanced imaging and their images are scored using PI-RADS v2. Imaging findings will be compared on a per-target and per-biopsy-core basis to histology from MRI-US fusion biopsies performed within six months. Results will be compared to standard non-contrast sequences (T2-weighted and diffusion-weighted imaging) to see if gadopiclenol improves detection and classification of clinically significant disease.
Who should consider this trial
Good fit: Ideal candidates are men scheduled for a clinically indicated prostate MRI with contrast who are also scheduled or likely to undergo MRI-US fusion biopsy with histology results available within six months and who have not started prostate cancer treatment.
Not a fit: Patients who have already begun prostate cancer treatment, are on dialysis or have contraindicating kidney injury or chronic kidney disease, or who will not undergo biopsy are unlikely to benefit.
Why it matters
Potential benefit: If successful, gadopiclenol-enhanced MRI could make clinically significant prostate cancers easier to see and more accurately classify, improving biopsy targeting and treatment decisions.
How similar studies have performed: Higher-relaxivity gadolinium agents have shown improved lesion conspicuity in several settings and limited data suggest similar benefits in prostate imaging, but gadopiclenol-specific evidence in prostate MRI is still limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Nicolas Bloch, MD — Columbia University
- Study coordinator: Nicolas Bloch, MD
- Email: bnb2134@cumc.columbia.edu
- Phone: 212 305 0519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, MRI, Prostate, Contrast Agent