Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-06 @ 6:45 PM
Study NCT ID:
NCT05596851
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.
Sponsor:
European Institute of Oncology
Organization:
Study Overview
Official Title:
PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
Detailed Description:
Study Phase: Phase II
Primary Objective:
To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.
Secondary Objectives:
* the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.
* safety and toxicity analysis regarding the intraoperative application of the β-probe.
* the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.
* the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens
Drug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11.
Primary Endpoint: Primary: sensitivity and specificity in a per-region analysis.
Secondary Endpoints:
* comparison of β-probe intra-operatory measurements with ex-vivo ones.
* comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV).
* comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).
Primary Objective:
To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.
Secondary Objectives:
* the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.
* safety and toxicity analysis regarding the intraoperative application of the β-probe.
* the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.
* the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens
Drug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11.
Primary Endpoint: Primary: sensitivity and specificity in a per-region analysis.
Secondary Endpoints:
* comparison of β-probe intra-operatory measurements with ex-vivo ones.
* comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV).
* comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).
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?: