PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- staging accuracy of PET/MRI in bladder cancer
研究概览
简要总结
Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers.
In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •invasive or locally advanced bladder cancer based on cystoscopic evaluation
- •Age: 18 to 85 years old
- •Language spoken: Finnish or Swedish
- •Mental status: Patients must be able to understand the meaning of the study
- •Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
排除标准
- •Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
- •Infections: Patient must not have an uncontrolled serious infection
- •Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- •Patient refusing radical cystectomy or chemotherapy
- •Intravesical Bacillus Calmette-Guerin instillations within 6 months
研究组 & 干预措施
MRI/PET
干预措施: MRI/acetate-PET imaging (Device)
结局指标
主要结局
staging accuracy of PET/MRI in bladder cancer
时间窗: 3 months
Accuracy of PET/MRI to stage newly diagnosed bladder cancer. MRI/PET staging results is compared to pathology report of TUR-BT and cystectomy specimens.
次要结局
- Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy(3 mo)
研究者
Peter Boström
chief, department of urology
Turku University Hospital