11C-Acetate PET and 18F-Choline PET in Bladder Carcinoma: Prospective Validation for the Preoperative Staging - PET with acetate and choline in bladder carcinoma
- Conditions
- 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.
- Registration Number
- EUCTR2004-004390-28-AT
- Lead Sponsor
- niv.-Kl.f.Nuklearmedizin Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method