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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BC patients eligible for radical cystectomy | Experimental | BC patients treated with radical cystectomy ± neoadjuvant therapy |
|
| BC patients treated with systemic therapy | Experimental | patients eligible for conservative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of FAPI PET/CT for the detection in the Staging of Bladder Cancer | 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). | from enrollment to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| PET Imaging | secondary outcome aims to image patients | from month 12 to 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Sollini | Contact | 0226436319 | sollini.martina@hsr.it | |
| Chiara Catalano | Contact | catalano.chiara@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Martina Sollini | IRCCS Ospedale San Raffaele | Principal Investigator |
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| FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment | Procedure | 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 |
|
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| D015653 | Cystectomy |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
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