Glucose Metabolic Response by PET/CT to Sarcoma Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine whether an FDA-approved device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
- Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
- Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
- Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
- Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).
Patients undergo fludeoxyglucose ^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed bone or soft tissue sarcoma
- •Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Not claustrophobic
- •Able to lie supine for 1 hour
- •Patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dL
排除标准
- •other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence
结局指标
主要结局
Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
时间窗: 6 months
次要结局
- •Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.(6 months)
- •Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.(6 months)
- •Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.(6 months)
- •Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.(6 months)