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Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Rome Tor Vergata
NCT07067749 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladd

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📋 Eligibility rules (as published)
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
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What it tests

  • multiparametric magnetic resonance imaging (mpMRI) of the bladder
  • Transurethral resection of bladder tumour (TURBt)
  • Circulating tumour DNA levels assessment
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Where

1 site
Policlinico Tor Vergata
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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