Patients with bladder carcinoma who are candidates for surgery. Patients with lymph node metastases benefit from preoperative chemotherapy but in case of negative lymph nodes they undergo a toxic treatment without benefit. CT and MRI are of limited value in lymph node staging and there is a need for more accurate non-invasive staging tests once the diagnosis is estblished by bladder biopsy.
Conditions
Interventions
Product Name: 11C-Acetate
Pharmaceutical Form: Injection*
Product Name: 18F-Choline
Pharmaceutical Form: Injection*
Sponsors
Univ.-Kl.f.Nuklearmedizin Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with newly diagnosed bladder cancer prior to surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Gravidity and nursing. WHO performance score >2. Patients with intractable claustrophoby. Patients with conditions that disables them to tolerate the scan duration of approx. 50 minutes. Excessively obese patients. Refusing to take part in the study. Patients incapable of giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare PET with 11C-acetate and 18F-fluorine in lymph node staging against CT and MRI for preoperative lymph node staging. Histology after surgery serves as gold standard.;Secondary Objective: To find out which of the both PET tracers is superior.;Primary end point(s): Surgery with histological evaluation of the locoregional lymph nodes. | — |
Countries
Austria
Outcome results
None listed