Actively Recruiting
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
Led by University of Rome Tor Vergata · Updated on 2025-07-24
92
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new diagnostic and treatment approach for muscle-invasive bladder cancer (MIBC) in a phase III randomized trial called TEMPO-MIBC. This study compares a standard treatment pathway involving surgical tumor resection with an experimental approach using multiparametric bladder MRI (mpMRI) to speed up care. The goal is to reduce the time to definitive treatment and possibly improve long-term cancer outcomes by avoiding some surgical procedures when mpMRI confirms muscle invasion. Participants are randomly assigned to one of two groups. The experimental group receives a bladder mpMRI to confirm muscle invasion and may skip the standard transurethral resection of bladder tumor (TURBt) surgery, moving directly to the next treatment step. The control group undergoes standard care with flexible cystoscopy, bladder biopsy, and TURBt surgery for staging. Both groups have their cases reviewed by a multidisciplinary board to decide on the best treatment, which is scheduled after shared decision-making with the patient. During the study, blood samples will be collected at three time points to measure circulating tumor DNA (ctDNA), which reflects tumor burden and treatment response. Researchers will track the time from enrollment to definitive treatment, cancer-specific and overall survival, time to recurrence, and procedure-related complications. Monitoring will continue for about two years to assess outcomes and safety. The study begins with baseline assessments and follows patients through their treatment and recovery periods.
CONDITIONS
Brief Title
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging
- Age 18 years or older
- Ability to provide written consent to participate
You will not qualify if you...
- Anticipated survival less than 3 months due to other health conditions
- Pregnant or breastfeeding patients
- Chemotherapy within the past 6 weeks
- Radiotherapy within the past 6 weeks
- TURBt procedure within the past 6 weeks
- Severe kidney impairment with eGFR less than 40 mL/min/1.73 m2
- Presence of metal implants incompatible with MRI
- Claustrophobia preventing MRI
- Refusal or inability to provide written consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 6 months until definitive treatment
Participants receive either standard management with a bladder tumour biopsy and transurethral resection of bladder tumour (TURBt) or simplified management with bladder mpMRI to guide treatment decisions for muscle invasive bladder cancer.
Visits for cystoscopy, biopsy, mpMRI or TURBt, and multidisciplinary treatment planning
Duration - Up to 2 years
Participants are monitored for procedure-related complications and cancer outcomes including survival and recurrence through study completion.
Periodic visits for monitoring and assessments
Trial Site Locations
Total: 1 location
1
Policlinico Tor Vergata
Rome, RM, Italy, 00133
Actively Recruiting
Research Team
S
Simone Albisinni, MD, Phd, FEBU
L
Luca Orecchia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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