Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:30 PM
Study NCT ID:
NCT05141760
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-06
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 prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: