High-resolution Intra-operative PSMA PET-CT in Prostate Cancer

Sponsor
IRCCS San Raffaele
Study ID
NCT06298838
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AURA10® Specimen PET/CT imager — DEVICE
    The AURA10 PET-CT specimen imager detects and measures the electron density distribution of a specimen and the radiotracer distribution within a specimen. The function of the system is to acquire and visualize PET and CT images of a specimen, based on which a healthcare professional can rapidly verify whether the correct tissue has been resected. It can be used in any condition that requires resection surgery to visualize the resected specimen. The device is automated and semi-quantitative, i.e., qualitative regarding visualization of structure and radiotracer distribution and quantitative regarding tissue density (Hounsfield units) and radiotracer uptake in the specimen (Bq/ml). The type of specimen required is resected tissue from a patient undergoing resection surgery.

Study Details

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.

Key Dates

First listed
Mar 7, 2024
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
10 participants (estimated)

Primary Outcome Measure

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 ]

Central Contacts

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