Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment.
PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.
详细描述
OBJECTIVES:
- Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision.
- Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray.
OUTLINE: This is a diagnostic study conducted concurrently with multimodality management.
Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging. Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal.
Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients undergo surgical resection 1-2 weeks later.
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 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
primary resectable rectal cancer
干预措施: chemotherapy (Drug)
primary resectable rectal cancer
干预措施: computed tomography (Procedure)
primary resectable rectal cancer
干预措施: conventional surgery (Procedure)
primary resectable rectal cancer
干预措施: neoadjuvant therapy (Procedure)
primary resectable rectal cancer
干预措施: positron emission tomography (Procedure)
primary resectable rectal cancer
干预措施: radionuclide imaging (Procedure)
primary resectable rectal cancer
干预措施: fludeoxyglucose F 18 (Radiation)
primary resectable rectal cancer
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan
时间窗: 2 years
at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision
次要结局
- Determine the accuracy of FDG-PET(2 years)
