Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815316
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-03-21
Brief Title:
18F-PSMA PETMRI for the Diagnosis of Clinically Significant Prostate Cancer
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Fully Hybrid 18F-PSMA PETMRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to evaluate the role of fully hybrid PETMRI with 18F-PSMA and multiparametric MR imaging mpMRI as one-stop approach for the diagnosis of clinically significant prostate cancer csPCa
This prospective PETMRI clinical evaluation will ideally reduce the number of false negative findings while at the same time allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk clinically indolent PCa
The demonstration that compared to mpMRI alone the use of PETMRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test in addition to mpMRI in daily clinical practice
This prospective PETMRI clinical evaluation will ideally reduce the number of false negative findings while at the same time allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk clinically indolent PCa
The demonstration that compared to mpMRI alone the use of PETMRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test in addition to mpMRI in daily clinical practice
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None