Imaging of Bladder Cancer Using Clinical 3 Tesla MRI and EX-VIVO Ultra-High-Field MRI.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Agreement in tumor staging between pathology and 3 Tesla MRI
研究概览
简要总结
RATIONALE: New diagnostic procedures, such as 3 Tesla magnetic resonance imaging (MRI), may help find bladder cancer and learn the extent of disease.
PURPOSE: This clinical trial is studying how well 3 Tesla MRI works in finding cancer in patients with bladder cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate whether 3 Tesla MRI can accurately determine the primary tumor (T) stage and pelvic lymph nodes (N) stage in patients with localized bladder cancer as compared to histopathology staging.
Secondary
- To determine whether 3 Tesla MRI can determine if the primary bladder tumor is responding to neoadjuvant chemotherapy at the mid-point of the planned treatment (after 2 courses).
- To assess whether an ex-vivo ultra-high-field MRI (4.7-11.7 Tesla) tissue scan can more accurately determine clinical stage of a primary bladder tumor and local extent of the disease (i.e., involvement of contiguous organs and regional lymph nodes) as compared to histopathology staging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Known bladder cancer
- •Scheduled for radical cystectomy and lymph node dissection.
- •Able and willing to give valid written informed consent.
- •No contraindications to the MRI(magnetic resonance imaging).
排除标准
- •Not pregnant, planning to become pregnant during the study, or nursing.
- •No allergy to contrast agents.
- •Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate(eGRF) less than 30 mL/min/1.73m
- •Any condition conflict based on the investigation's clinical judgment that would prevent the patient from completion all trial assessments and visits.
- •Inability or unwillingness to cooperate with requirements of this trial.
- •Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR.
- •Patients with sickle cell anemia and other hemolytic anemia.
研究组 & 干预措施
MRI+surgery
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
干预措施: Specimen Ultra-High field MRI (Procedure)
MRI+surgery
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI
干预措施: Cystectomy and Lymphadenectomy (Procedure)
MRI+surgery+chemotherapy
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
干预措施: Specimen Ultra-High field MRI (Procedure)
MRI+surgery+chemotherapy
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
干预措施: chemotherapy (Drug)
MRI+surgery+chemotherapy
3 Tesla MRI/Cystectomy and Lymphadenectomy/Urinary Diversion/Specimen Ultra-High field MRI/chemotherapy
干预措施: Cystectomy and Lymphadenectomy (Procedure)
结局指标
主要结局
Agreement in tumor staging between pathology and 3 Tesla MRI
时间窗: up to 24 months
次要结局
- Agreement in lymph node staging between pathology and 3 Tesla MRI(up to 24 months)
研究者
Michael V Knopp MD PhD
Principal Investigator
University of Cincinnati