Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
研究概览
简要总结
The purpose of this study is to help researchers investigate if a new imaging agent named 18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well as whether disease will reoccur in the future. The study will also investigate whether a 18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will respond to standard therapy. Information obtained from this study may help doctors design future studies in which they may target tumor areas that do not respond to therapy or may likely reoccur in the future.
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
- •Pathologic confirmation of NSCLC at MSKCC
- •No prior treatment for this diagnosis of NSCLC
- •Patient to be treated with neoadjuvant chemotherapy (35 patients total) or patient to be treated with definitive RT,sequential chemo-RT, or concurrent chemo-RT (minimum dose of 50 Gy in 25 fractions) (25 patients total)
- •Tumor must measure ≥ 2cm on CT
- •Age ≥ 18 years
- •Ability to hold the breath for 10 seconds.
- •Karnofsky performance status ≥ 70%
- •Women of childbearing age must have a negative blood pregnancy test
排除标准
- •Women who are pregnant or breast-feeding
- •Severe diabetes (fasting Blood Glucose > 200 mg/dl)
研究组 & 干预措施
18F-FMISO PET/CT
All enrolled patients will undergo a baseline 18F-FDG PET scan as part of their standard clinical treatment for NSCLC. Dynamic 18F-FMISO PET scans will be performed on one of the GE PET/CT scanners in 3D mode, at least one day after the baseline 18F-FDG PET scan. The dynamic baseline 18F-FMISO studies may precede the 18F-FDG study if the patient had a CT or PET/CT scan within the last 30 days that would permit the investigators to localize the tumor of interest during the 18F-FMISO study. In a group of 5 patients, the feasibility of simultaneous imaging of 18F-FMISO and 18F-FDG will be assessed. The patient will have an IV line placed for radiotracer injection and for venous blood sampling. All dynamic PET scans will be performed over one PET FOV centered at the lesion position. The 18F-FDG mid-treatment PET/CT scan will be performed over only one bed position.
干预措施: 18F-FMISO (Drug)
18F-FMISO PET/CT
All enrolled patients will undergo a baseline 18F-FDG PET scan as part of their standard clinical treatment for NSCLC. Dynamic 18F-FMISO PET scans will be performed on one of the GE PET/CT scanners in 3D mode, at least one day after the baseline 18F-FDG PET scan. The dynamic baseline 18F-FMISO studies may precede the 18F-FDG study if the patient had a CT or PET/CT scan within the last 30 days that would permit the investigators to localize the tumor of interest during the 18F-FMISO study. In a group of 5 patients, the feasibility of simultaneous imaging of 18F-FMISO and 18F-FDG will be assessed. The patient will have an IV line placed for radiotracer injection and for venous blood sampling. All dynamic PET scans will be performed over one PET FOV centered at the lesion position. The 18F-FDG mid-treatment PET/CT scan will be performed over only one bed position.
干预措施: PET/CT (Other)
结局指标
主要结局
The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
时间窗: 3 days from baseline
The difference between two baseline 18F-FMISO PET scans three days apart to assess the reproducibility.
Progression-free Survival (PFS)
时间窗: 3 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Overall Survival(3 years)