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

NCT07257718 | Not Yet Recruiting Phase 2

• 1 other identifier: FUTURE
• Study Type: interventional
• Target: 262
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PET Imaging

  from month 12 to 60

Study Arms (2)

BC patients eligible for radical cystectomy

EXPERIMENTAL

BC patients treated with radical cystectomy ± neoadjuvant therapy

Procedure: FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy

BC patients treated with systemic therapy

EXPERIMENTAL

patients eligible for conservative treatment

Procedure: FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment

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

BC patients eligible for radical cystectomy

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

BC patients treated with systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• ECOG performance status \< 2
• ability to undergo an imaging study procedure

You may not qualify if:

• pregnant or breast-feeding women
• uncontrolled active infection.

Sponsors & Collaborators

• Chiti Arturo: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Liquid Biopsy; Cystectomy; Conservative Treatment

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Officials

• Martina Sollini

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Sollini

CONTACT

0226436319; sollini.martina@hsr.it

Chiara Catalano

CONTACT

catalano.chiara@hsr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: December 2, 2025

Record last verified: 2025-10