Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838626
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2021-04-07
Brief Title:
Study of Diagnostic Performance of 18FCTT1057 for PSMA-positive Tumors Detection
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase IIIII Study for Evaluation of the Diagnostic Performance of 18FCTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth
Status:
COMPLETED
Status Verified Date:
2024-02
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:
GuideView
Brief Summary:
The purpose of this study is to evaluate the diagnostic performance of 18FCTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth SoT Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer PCa will be used for the histopathology assessments
Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable ie have both an evaluable PETCT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PETCT and surgery which will be required for the calculation of the co-primary endpoints
Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable ie have both an evaluable PETCT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PETCT and surgery which will be required for the calculation of the co-primary endpoints
Detailed Description:
This is a multi-center single-arm open-label prospective study to evaluate the diagnostic performance of 18FCTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as SoT Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk PCa will be used for the histopathology assessments
All participants will receive 18FCTT1057 for PETCT scan imaging and surgery radical prostatectomy and extended pelvic lymph node dissection will be performed up to 6 weeks after but not sooner than 48 hours after the completion of the 18FCTT1057 PETCT scan for pathology assessment of the tissue specimens
The co-primary endpoints of patient-level sensitivity and region-level specificity will be assessed by comparing the central reading results of the 18FCTT1057 PET scan to the histopathology results in the dissected tissue specimens ie both the primary tumor and the dissected Pelvic Lymph Node PLN
Pathology will be assessed by the local pathologists as per Standard of Care SoC who will be blinded to the PET data
All participants will receive 18FCTT1057 for PETCT scan imaging and surgery radical prostatectomy and extended pelvic lymph node dissection will be performed up to 6 weeks after but not sooner than 48 hours after the completion of the 18FCTT1057 PETCT scan for pathology assessment of the tissue specimens
The co-primary endpoints of patient-level sensitivity and region-level specificity will be assessed by comparing the central reading results of the 18FCTT1057 PET scan to the histopathology results in the dissected tissue specimens ie both the primary tumor and the dissected Pelvic Lymph Node PLN
Pathology will be assessed by the local pathologists as per Standard of Care SoC who will be blinded to the PET data
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003958-67 | EUDRACT_NUMBER | None | None |