High-resolution Intra-operative PSMA PET-CT in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AURA10® Specimen PET/CT imager.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study
Overview
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.
Interventions
- Device AURA10® Specimen PET/CT imager
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.
Primary outcome measures
- 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 outcome measures (1)
- Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection [Time frame: 1 YEAR]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06298838 · XEOS study