NCT07257718

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Chiti Arturo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-09-01
• Completion: 2031-09-01
• First posted: 2025-12-02
• Last updated: 2025-12-02