MRI-first treatment pathway for muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.