Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-25 @ 4:09 PM
Study NCT ID:
NCT05197257
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2021-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
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:
Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
Detailed Description:
This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.
Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.
One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.
The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.
Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.
One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: