Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 10
- Primary Endpoint
- To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .
The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.
Investigators
Giorgio Gandaglia
Assistant Professor
IRCCS San Raffaele
Eligibility Criteria
Inclusion Criteria
- •Male patient, 18 years of age or older.
- •Patient is confirmed with high risk prostate cancer.
- •Patient is indicated to undergo radical prostatectomy and ePLND.
- •Patient is estimated compliant for study participation by the investigator.
- •Patient has freely given his/her informed consent to participate in this study.
Exclusion Criteria
- •Patient has general or local contra-indications for radical prostatectomy.
- •Patient has active viral or fungal infection.
- •Patient previously received radiotherapy of the prostate.
- •Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.
Outcomes
Primary Outcomes
To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard
Time Frame: 1 YEAR
Secondary Outcomes
- Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection(1 YEAR)