Bladder CancerPhase 2FUTURENCT07257718
The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer - FUTURE Trial
A Phase 2 study testing FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy and FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment in people with Bladder Cancer, run by Chiti Arturo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy and FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- ECOG performance status < 2
- ability to undergo an imaging study procedure
Who cannot join
- pregnant or breast-feeding women
- uncontrolled active infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Chiara Catalano contact
About this study
Official title: The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer
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
- Being tested
- FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy, FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomyProcedure or surgery
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 treatmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| BC patients eligible for radical cystectomy | Experimental | BC patients treated with radical cystectomy ± neoadjuvant therapy Receives: 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 Receives: Procedure: FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from enrollment to 48 months
Secondary outcomes (1)
PET Imaging
secondary outcome aims to image patients
Measured: from month 12 to 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiti Arturo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiti Arturo, IRCCS San Raffaele
- Investigators
- Martina Sollini, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257718
- Sponsor's protocol ID
- FUTURE
- Acronym
- FUTURE
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer
- ClinicalTrials.gov ID
- NCT07257718
- Acronym / sponsor ID
- FUTURE / FUTURE
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Chiti ArturoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BC patients eligible for radical cystectomy | Experimental | Procedure: FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomyBC patients treated with radical cystectomy ± neoadjuvant therapy |
| BC patients treated with systemic therapy | Experimental | Procedure: FAPI PET/CT and liquid biopsy in patients eligible for conservative treatmentpatients eligible for conservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- ECOG performance status < 2
- ability to undergo an imaging study procedure
Key exclusion criteria (2 listed)
- pregnant or breast-feeding women
- uncontrolled active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomyWe 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 or surgery | BC patients eligible for radical cystectomy |
| FAPI PET/CT and liquid biopsy in patients eligible for conservative treatmentWe 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 or surgery | BC patients treated with systemic therapy |
Primary outcome
Sensitivity of FAPI PET/CT for the detection in the Staging of Bladder Cancer
Time frame: from enrollment to 48 months
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).
1 secondary outcome
PET Imaging
Time frame: from month 12 to 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiara Catalano contact
Martina Sollini principal investigator
IRCCS Ospedale San Raffaele
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy and FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment in people with Bladder Cancer, run by Chiti Arturo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Sollini (0226436319, sollini.martina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of FAPI PET/CT for the detection in the Staging of Bladder Cancer (time frame: from enrollment to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.