The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer - FUTURE Trial
NCT ID: NCT07257718
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
262 participants
INTERVENTIONAL
2026-09-30
2031-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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BC patients eligible for radical cystectomy
BC patients treated with radical cystectomy ± neoadjuvant therapy
FAPI 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
BC patients treated with systemic therapy
patients eligible for conservative treatment
FAPI 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
Interventions
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FAPI 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
FAPI 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
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status \< 2
* ability to undergo an imaging study procedure
Exclusion Criteria
* uncontrolled active infection.
18 Years
ALL
No
Sponsors
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Chiti Arturo
OTHER
Responsible Party
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Chiti Arturo
Professor
Principal Investigators
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Martina Sollini
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Central Contacts
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Other Identifiers
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FUTURE
Identifier Type: -
Identifier Source: org_study_id
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