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

ConditionProstate Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age18-80

SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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) according to the European Association of Urology (EAU) guidelines.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial 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

Time frame

1 YEAR

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Source ClinicalTrials.gov

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