Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate
研究概览
简要总结
Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years.
Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC).
Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.
详细描述
Background:
Bladder cancer is the second most frequent genito-urinary cancer, and the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Curative treatment of muscle invasive urothelial carcinoma localized to the bladder includes cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy with lymph nodes dissection. Nonetheless, surgery indications depend on pre-operative staging regarding nodes and metastatic involvement.
Computed Tomography (CT) scan is the reference imaging study for loco-regional and metastatic staging. Lymph node involvement evaluation is based on morphologic criteria only. Its sensitivity lies between 30 and 53% and its specificity between 67 and 91%. Yet, optimal node staging is crucial for therapeutic decision.
FDG-Positron Emission Tomography (PET) CT, using both morphologic and functional criteria, could help for node staging in muscle invasive bladder cancer assessment, especially by detecting infracentimetric involved lymph nodes. Moreover, it could be useful for detecting distant metastasis.
Objective
To evaluate the accuracy of the PET CT for lymph node staging and to determine the rate of treatment modification according to PET CT results Methods: Retrospective study based on the medical records of every patient undergoing a PET CT at the time of diagnosis of MIBC from 01/2005 to 12/2017 in Bordeaux (Bergonie Institute and University Hospital). PET CT could have been done before any treatment (PET 1) and/or after neo-adjuvant chemotherapy and before surgery (PET 2).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of Muscle Invasive Urothelial Carcinoma of the bladder (classified at least pT2 on TURB)
- •Diagnosis between January 2005 and December 2017
- •PET CT done during initial assessment before surgery (at the time of diagnosis and/or after neoadjuvant chemotherapy)
- •Management of cancer at Institut Bergonié or at Bordeaux University Hospital
- •Previous treatment for Non Muscle Invasive Bladder Cancer allowed
排除标准
- •Management of cancer outside of Institut Bergonié or Bordeaux University Hospital
- •No PET CT done during initial assessment (before surgery)
- •Rare pathological type of bladder cancer without urothelial carcinoma (epidermoid carcinoma, neuro-endocrine carcinoma, …)
- •Extra-vesical urothelial carcinoma
结局指标
主要结局
Accuracy of the PET CT for Lymph Node Staging in Terms of Sensitivy Rate
时间窗: 16 weeks after inclusion
Performance sensitivity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection). Gold standard : pathological results (complete response vs no complete response). Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response. Sensitivity rate : count of participants with complete response as per FDG-PET divided by count of participants with pathoplogical complete response
Accuracy of the PET CT for Lymph Node Staging in Terms of Specificity Rate
时间窗: Date of pathological results, up to 20 weeks after inclusion
Performance specificity of FDG-PET CT for LN staging on diagnosis of MIBC (before and after NAC and before cystectomy and LN dissection). Gold standard : pathological results (complete response vs no complete response). Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response Specificiity rate : count of participants with NO complete response as per FDG-PET divided by count of participants with NO pathoplogical complete response
次要结局
未报告次要终点