bladder cancer urothelial cell carcinoma
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -All patients with a clinical diagnosis of muscle invasive bladder cancer with active disease identified within the bladder at the time of consent and imaging. -Patients with primary resectable tumour in the bladder, clinically suspect of invasive bladder carcinoma, who are potential candidates for radical cystectomy plus lymphadenectomy, will be eligible with residual disease in the bladder at the time of imaging. -All patients will have consented to diagnostic imaging procedures.
Exclusion criteria
Exclusion criteria: - Prior biopsy of the primary bladder tumour within 6 months before PET/CT imaging - Prior BCG instillations. - Treatment with bladder instillations other than with BCG less than 6 months ago - Patients with sarcoidosis, tuberculosis and/or lymphatic disorders * Prior pelvic radiation for bladder cancer - Patients deemed not appropriate surgical candidates - Patients that cannot tolerate being in the PET scanner or deemed unable to receive a contrast enhanced CT. - Patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the predictive accuracy of 18F-FDG PET/CT in comparison to conventional work-up with contemporary CT scan for the preoperative detection of nodal metastases in patients with invasive T2-T3 bladder cancer through detailed comparison of CT imaging and pathologic findings following radical cystectomy. To test differences in diagnostic performance between the 2 imaging procedures for significance by the paired sample comparison with a significance level of .05 and a power of 0.8 superiority of PET/CT over CT will be determined aiming at an improvement of 10% in specificity and/or an improvement of 10% in sensitivity (PET/CT being superior). Sensitivities, specificities, negative predictive values, positive predictive values, and accuracies (with exact 95% confidence intervals [CIs]) for both modalities will be determined for detection of metastases to lymph nodes as well as for distant metastases. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To identify the extent to which FDG-PET/CT results may affect clinical decision making in patients with muscle-invasive bladder cancer. - To identify whether PET/CT is better in detecting (possible) distant metastases than contemporary diagnostic CT. - To test the difference in accuracy between PET/low dose CT (without contrast) versus PET/high dose CT (with oral and intravenous contrast). - To collect tissues from primary tumour and lymph nodes for research on bladder cancer in general and more specifically to investigate which tumour and lymph node characteristics relate to clinical staging, and 2 year cancer-specific outcome. | — |
Countries
Netherlands
Outcome results
None listed