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

Обзор

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 bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes. A blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.

Вмешательства

• Диагностический тест multiparametric magnetic resonance imaging (mpMRI) of the bladder
  This study will investigate the role of bladder mpMRI as a tool to expedite treatment in patients with muscle invasive bladder cancer. mpMRIs will be investigated as a possible replacement of standard TURBt, a planned surgical procedure for cancer local staging. mpMRis will be reported according to the Vesical Imaging - Reporting and Data System Stanrdars (VI-RADS) to provide a score indicating probability of muscle invasion.
• Процедура Transurethral resection of bladder tumour (TURBt)
  This is a planned endoscopic surgical procedure consisting in resection of the bladder tumour through a electrified loop manouvred with an endoscope. In muscle invasive bladder cancer, this procedure allows histological confirmation of presence of detrusor muscle invasion.
• Генная терапия Circulating tumour DNA levels assessment
  Blood samples will be collected from each enrolled patient at pre-planned time points: 1. Cystoscopy, both arms 2. mpMRI (experimental arm) or TURBt (control arm) 3. Definite cancer treatment, both arms ctDNA levels will be measured on the collected blood samples.

Первичные конечные точки

• Time to definitive treatment [Срок оценки: From the day of enrollment at baseline until the day of the start of definitive treatment for muscle invasive bladder cancer. Expected timeframe between 45 and 180 days.]

Вторичные конечные точки (5)

• Concentration of ctDNA levels [Срок оценки: Three specific time points: 1) Enrolment at baseline 2) During intervention (mpMRI or TURBt) 3) On the day of definitive treatment for muscle invasive cancer Expected timeframe 1 to 180 days]
• Cancer Specific Survival [Срок оценки: through study completion, an average of 2 years]
• Overall Survival [Срок оценки: through study completion, an average of 2 years]
• Time to cancer recurrence [Срок оценки: "through study completion, an average of 2 years".]
• Number of procedure Related Complications [Срок оценки: For 30 days following the procedure]

Критерии участия

Критерии включения

• Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Policlinico Tor Vergata — Rome

Идентификаторы

NCT: NCT07067749 · 315.24CET2 ptv

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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