The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer - FUTURE Trial

Sponsor
Chiti Arturo
Study ID
NCT07257718
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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

Study Details

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.

Key Dates

First listed
Dec 2, 2025
Start date
Sep 30, 2026
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2031

Study Design

Enrollment
262 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: BC patients eligible for radical cystectomy
    BC patients treated with radical cystectomy ± neoadjuvant therapy
  • Experimental: BC patients treated with systemic therapy
    patients eligible for conservative treatment

Primary Outcome Measure

Sensitivity of FAPI PET/CT for the detection in the Staging of Bladder Cancer [ Time Frame: from enrollment to 48 months ]

Central Contacts

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