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

Prostate Cancer Clinical Trial

Official title:

Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298838
• Other study ID #: XEOS study
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: GIORGIO GANDAGLIA
• Phone: +39 02 26438068
• Email: gandaglia.giorgio[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male patient, 18 years of age or older.

2. Patient is confirmed with high risk prostate cancer.

3. Patient is indicated to undergo radical prostatectomy and ePLND.

4. Patient is estimated compliant for study participation by the investigator.

5. Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria:

1. Patient has general or local contra-indications for radical prostatectomy.

2. Patient has active viral or fungal infection.

3. Patient previously received radiotherapy of the prostate.

4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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., 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 YEAR
Secondary	Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection		1 YEAR