Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847348
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-05
Brief Title:
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
Sponsor:
Telix Pharmaceuticals Innovations Pty Limited
Organization:
Telix Pharmaceuticals Innovations Pty Limited
Study Overview
Official Title:
A Prospective Open-Label Single-Arm Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PETCT or PETMRI in Patients With Biochemical Recurrent Prostate Cancer
Status:
RECRUITING
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 is a prospective open-label single-arm multicenter bridging study in Chinese patients with prostate cancer This multicenter study is planned to be conducted in patients with biochemical recurrence BCR of elevated PSA after radical prostatectomy or radical radiotherapy This study investigates how well 68Ga-PSMA-11 PETCT works in detecting BCR prostate cancer in Chinese patient 68Ga-PSMA-11 developed by Telix is a new molecular entity tracer with the trade name Illuccix which is approved by FDA for the examination of 1 patients with suspected metastatic PC who are scheduled for initial treatment 2 patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None