MRI-first treatment pathway for muscle-invasive bladder cancer
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
This trial tests whether using a multiparametric bladder MRI to skip a staging TURBt can speed up care for people with biopsy-proven muscle-invasive bladder cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT07067749 on ClinicalTrials.gov |
What this trial studies
TEMPO-MIBC is a phase III, single-center, randomized two-arm trial comparing a simplified MRI-driven pathway to standard management for patients with clinical suspicion of detrusor muscle invasion. In the experimental arm, patients receive a multiparametric bladder MRI (mpMRI) and, if imaging confirms high suspicion of muscle invasion, immediate progression to the next clinical management step without a conventional staging TURBt. The control arm follows standard care with TURBt for staging before further treatment. Circulating tumor DNA levels are also collected as a biomarker and time-to-treatment and pathway efficiency are primary outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with biopsy-proven bladder cancer and cystoscopic or pre-imaging features suggesting detrusor muscle invasion who are eligible for MRI and definitive therapy.
Not a fit: Patients with MRI contraindications (non-compatible metal implants, claustrophobia), severe renal impairment, recent chemo/radiotherapy/TURBt, pregnancy or breastfeeding, or very limited life expectancy are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could shorten time to definitive treatment, reduce the need for an extra endoscopic procedure, and streamline patient care.
How similar studies have performed: Multiparametric bladder MRI and the VI-RADS scoring system have shown promising diagnostic accuracy in prior studies, but large randomized phase III evidence changing standard practice is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging Exclusion Criteria: * Anticipated survival \< 3 months due to comorbidities * Pregnant patients * Breastfeeding patients * Previous chemotherapy within 6 weeks * Previous radiotherapy withing 6 weeks * Previous TURBt within 6 weeks * Severe renal impairment (eGFR \< 40 mL/min/1.73 m2) * non MRI-compatible metal implants * Claustrophobia * Denial of written consent to participate in the study
Where this trial is running
Rome, RM
- Policlinico Tor Vergata — Rome, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Simone Albisinni, MD, Phd, FEBU — Fondazione PTV Policlinico Tor Vergata
- Study coordinator: Simone Albisinni, MD, Phd, FEBU
- Email: simone.albisinni@ptvonline.it
- Phone: +390620902977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.