Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 19
- 主要终点
- Progression free survival
研究概览
简要总结
A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (18+ years of age)
- •Clinically suspected MIBC
- •No lymph node or distant metastases
- •Written informed consent
排除标准
- •Unable or unwilling to undergo mpMRI
- •Unfit for TURBT
- •Unfit for definitive treatment with curative intent
- •A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment
研究组 & 干预措施
mpMRI plus a same-day cystoscopic bladder biopsy
multiparametric MRI plus same-day cystoscopic bladder biopsy
干预措施: mpMRI plus a same-day cystoscopic bladder biopsy (Diagnostic Test)
TURBT
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
干预措施: TURBT (Procedure)
结局指标
主要结局
Progression free survival
时间窗: 2 years
Progression-free survival, defined as the time between randomisation and one of the following events, whichever occurs first: * Diagnosis of distant metastases * Diagnosis of loco-regional nodal recurrence * Death from any cause
次要结局
- Time to definitive treatment(2 years)
- Health-related quality of life(2 years)
- Hospital-related healthcare costs(2 years)
- Cost-effectiveness(2 years)
- Circulating tumor cells(Before (at least on same day) and after (max. 60 minutes) TURBT)
- Metastatic potential of CTC-positive samples(Before (at least on same day) and after (max. 60 minutes) TURBT)