Feasibility and accuracy of intraoperative molecular PET imaging to improve complete tumor resectio

Conditions: Malignant neoplasm of prostate
C61

Registration Number: DRKS00032673

Lead Sponsor: niversitätsmedizin Essen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Male

Target Recruitment: 120

Inclusion Criteria

General inclusion criteria: Patients with an age = 18 years.

Renal cell carcinoma-specific:
•Indication for nephron-sparing surgery or nephrectomy.
•Indication for resection of a local recurrence
•Preoperative staging for renal cell carcinoma according to current guidelines

Prostate cancer-specific:
•Histologically confirmed adenocarcinoma of the prostate.
•Preoperative mpMRI for staging prior to surgery.
•At least unfavorable intermediate risk prostate carcinoma:
oCategory cT2 according to the TNM classification or
oISUP GG3 and
oPSA >10 ng/ml
•Indication for radical prostatectomy.
•Preoperative staging for prostate cancer according to the current guidelines

Urothelial carcinoma specific:
•Histologically confirmed urothelial carcinoma.
•Indication for cystectomy or nephroureterectomy
•Preoperative staging of urothelial carcinoma according to the current guidelines.

Exclusion Criteria

Patients will be excluded if one or more of the following criteria are met:
•Known hypersensitivity to the diagnostic PET agent or its components
•Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders)
•Prior administration of another PET tracer of any type in the period of 8 half-lives of the radionuclide
•Contraindication for surgery (e.g. polymetastases)

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection rate of positive surgical margins during tumor resection using intraoperative PET/CT with a tumor-dependent tracer (68Ga / 18F / 89Zr – PSMA/FDG/Girentuximab) compared to histopathology.

Secondary Outcome Measures

Name	Time	Method
•To compare the diagnostic accuracy of intraoperative specimenPET/CT with conven-tional frozen section examination.<br>•Intraoperative detection rate of positive lymph nodes by intraoperative PET/CT.<br>•Evaluation of radiation exposure of medical staff (surgical team and pathology)<br>•Comparison of tumor burden of whole-body PET/CT with intraoperative PET/CT using machine learning-based image analysis.