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临床试验/NCT02662166
NCT02662166已完成不适用

Magnetic Resonance Imaging of Bladder Cancer

Turku University Hospital3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
3
主要终点
Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer

研究概览

简要总结

Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.

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

入选标准

  • Age: 18 to 85 years old
  • Suspected BC based on cystoscopical evaluation.
  • 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

  • History of serious cardiovascular, liver or kidney disease
  • Uncontrolled serious infection
  • Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  • Patient refusing radical cystectomy or chemotherapy or BCG
  • Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination

结局指标

主要结局

Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer

时间窗: 24 months

The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens

次要结局

  • Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)(24 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Peter Boström

MD, PhD, Deah of Department

Turku University Hospital

研究点 (3)

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