A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Changes From Baseline Hypoxic Volume (HV)
研究概览
简要总结
This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the potential of 18F-fluoromisonidazole ([18F] FMISO) as a non-invasive indicator of tissue hypoxia to provide tumor-imaging data that correlates with tissue markers of hypoxia in patients with soft tissue sarcoma treated with neoadjuvant chemotherapy with or without radiotherapy.
SECONDARY OBJECTIVES:
I. Test [18F] FMISO tumor uptake as an independent predictor of patient outcome and if it provides additional predictive power over fludeoxyglucose F 18 PET scan.
II. Test [18F] FMISO tumor uptake as a predictor of response in the subgroup of patients treated with radiotherapy and chemotherapy.
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 confirmed intermediate- or high-grade soft tissue sarcoma
- •Biopsy proven or highly suspicious primary or recurrent disease
- •Tumor size ≥ 2 cm
- •Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
- •Life expectancy ≥ 12 months
- •Negative pregnancy test
- •Willing to undergo PET scanning
- •Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)
- •Able to lie on the imaging table for up to 1.5 hours
- •Weight ≤ 400 lbs
- •Not pregnant
排除标准
- 未提供
结局指标
主要结局
Changes From Baseline Hypoxic Volume (HV)
时间窗: Baseline and up to 2 years
ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.
次要结局
- Overall Survival(Up to 2 years)
- Disease Free Survival(From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years)
- Response to Radiation Therapy (XRT) by RECIST Criteria(Up to 2 years)