Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.
研究概览
简要总结
This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years old or greater at the time of consent.
- •Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.
- •ECOG Performance Status of 0-
- •Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).
- •Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.
排除标准
- •Prior TURBT within 120 days of study entry.
- •Prior therapy for bladder cancer within 180 days of study entry.
- •Inability to tolerate mpMRI or associated contrast.
- •Inability to tolerate TURBT or associated anesthesia.
- •ECOG Performance Status of
- •Female patient who is known to be pregnant or breastfeeding.
研究组 & 干预措施
mpMRI + Diagnostic TURBT
干预措施: mpMRI + Diagnostic TURBT (Diagnostic Test)
结局指标
主要结局
Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT.
时间窗: Up to 1 year
VI-RADS is a five-point scoring system developed to standardize imaging and reporting of bladder tumor invasiveness on mpMRI. It predicts the degree of possible muscular propria invasion ("muscle-invasiveness") of bladder tumors. Once diagnostic TURBT is performed, the VI-RADS score from mpMRI will be compared to the pathologic tumor (T) stage from a diagnostic TURBT to assess for concordance.
次要结局
- Patient Quality of Life with mpMRI versus diagnostic TURBT.(up to 5 years)
- Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy(up to 5 years)
- Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI).(up to 5 years)
- Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT(up to 5 years)
- Progression free survival (PFS) with mpMRI compared to diagnostic TURBT(up to 5 years)
- Incidence of adverse events with mpMRI versus diagnostic TURBT.(up to 5 years)
- Incidence of repeat TURBT.(up to 5 years)
研究者
Nataliya Mar
Associate Professor
University of California, Irvine