Bladder Cancer
Conditions
Brief summary
The study will be a prospective two arms diagnostic phase II single-center trial. Patients referred for diagnosis and treatment with diagnosis of bladder cancer, age \> 18 years, ECOG performance status \< 2, ability to undergo an imaging study procedure will be considered for inclusion. For the study will be include 262 patients (118 and 144 in the arm 1 and 2, respectively). Eligible patients will sign the inform consent to be included in the study. The participation to other clinical studies will be not, per se, an exclusion criterion. Before treatment, enrolled patients will be imaged by FAPI PET/CT and urine samples will be collected and analyzed by Epicheck® test and Xpert® Bladder Cancer Detection. Thereafter, patients will be managed and treated according to international guidelines and standard of care procedures in our institution. Safety will be recorded. Results of FAPI imaging, Epicheck® test, and Xpert® Bladder Cancer Detection will be compared to stage, risk assessment groups as defined by currentguidelines, and clinical outcome. Diagnostic and predictive performances of FAPI imaging and liquid biopsy will be assessed and compared by using machine learning approaches.
Interventions
PROCEDUREFAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy
We hypothesise that FAPI PET improves clinical staging, and that baseline FAPI PET metrics and ctDNA/utDNA profiles correlate with tumour aggressiveness and patient outcomes
PROCEDUREFAPI PET/CT and liquid biopsy in patients eligible for conservative treatment
We hypothesise that FAPI PET improves clinical staging, and that baseline FAPI PET metrics and ctDNA/utDNA profiles correlate with tumour aggressiveness and patient outcomes
Sponsors
Chiti Arturo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * ECOG performance status \< 2 * ability to undergo an imaging study procedure
Exclusion criteria
* pregnant or breast-feeding women * uncontrolled active infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of FAPI PET/CT for the detection in the Staging of Bladder Cancer | from enrollment to 48 months | Sensitivity will be calculated as the proportion of true positive findings obtained with FAPI PET/CT compared with the reference standard (e.g., clinical follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PET Imaging | from month 12 to 60 | secondary outcome aims to image patients |
Contacts
Primary ContactMartina Sollini
Backup ContactChiara Catalano
Outcome results
None listed