C61
Conditions
Interventions
Group 1: Intraoperative specimen PET/CT
Sponsors
Universitätsmedizin Essen
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
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: o Category cT2 according to the TNM classification or o ISUP GG3 and o PSA >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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • To compare the diagnostic accuracy of intraoperative specimenPET/CT with conven-tional frozen section examination. • Intraoperative detection rate of positive lymph nodes by intraoperative PET/CT. • Evaluation of radiation exposure of medical staff (surgical team and pathology) • Comparison of tumor burden of whole-body PET/CT with intraoperative PET/CT using machine learning-based image analysis. | — |
Countries
Germany
Contacts
Public ContactChristopher Darr
Universitätsmedizin Essen
Outcome results
None listed