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

Chiti Arturo

Status and phase: Begins enrollment in 6 months; Phase 2

Conditions: Bladder Cancer

Treatments: Procedure: FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy; Procedure: FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07257718

FUTURE

Details and patient eligibility

About

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.

Enrollment: 262 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

262 participants in 2 patient groups

BC patients eligible for radical cystectomy

Experimental group

Description:

BC patients treated with radical cystectomy ± neoadjuvant therapy

Treatment:

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

BC patients treated with systemic therapy

Experimental group

Description:

patients eligible for conservative treatment

Treatment:

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