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Trial Title:
Gadopiclenol in Contrast Enhanced MRI of the Prostate
NCT ID:
NCT06226129
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
MRI
Prostate
Contrast Agent
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gadopiclenol
Description:
Gadopiclenol for contrast enhanced MRI
Arm group label:
Gadopiclenol
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.
Detailed description:
Gadolinium based contrast agents with higher relaxivity have been shown to improve
contrast enhancement and differentiation of tissues with increased blood perfusion or
with higher microvascular density (MVD), and therefore increase visibility of cancerous
tissue. In this study, the objective is to demonstrate that Gadopiclenol facilitates the
detection and classification of clinically significant prostate cancer, compared to T2-W
(T2 weighted image) and diffusion weighted imaging (DWI), using the detailed
location-specific (individual biopsy core for each annotated target) results of
subsequently performed MRI-US fusion biopsies.
Criteria for 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 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UMass Medical School
Address:
City:
Worcester
Zip:
01655
Country:
United States
Start date:
February 14, 2024
Completion date:
February 1, 2028
Lead sponsor:
Agency:
University of Massachusetts, Worcester
Agency class:
Other
Collaborator:
Agency:
Guerbet
Agency class:
Industry
Source:
University of Massachusetts, Worcester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06226129
