Dynamic Perfusion Computed Tomography Changes After Stereotactic Body Radiation Therapy for Localized Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in blood flow (mL/min/100 g) as measured on perfusion CT
研究概览
简要总结
This pilot clinical trial studies the changes in dynamic perfusion computed tomography images before, during, and after stereotactic body radiation therapy in patients with stage I-II non-small cell lung cancer that has not spread to other parts of the body. Diagnostic imaging procedures, such as dynamic perfusion computed tomography, measure blood flow through tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving dynamic perfusion computed tomography images before, during, and after stereotactic body radiation therapy may help better understand how radiation therapy works to stop tumor growth in patients with non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To describe perfusion computed tomography (CT) parameters and their changes in non-small cell lung cancer (NSCLC) tumors prior to, during, 1 month after, and 3 months after stereotactic body radiation therapy (SBRT).
SECONDARY OBJECTIVES:
I. To correlate tumor perfusion parameters with clinical tumor response on follow up per standard of care.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Biopsy proven non-small cell lung cancer
- •Minimum tumor dimension >= 1 cm (preferably >= 2 cm)
- •No clinical evidence of nodal disease (N1-N3) as assessed by CT and/or positron emission tomography (PET)/CT
- •Zubrod performance status 0-2
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •No prior radiation to the same area
- •No concurrent chemotherapy
- •Evaluated by radiation oncologist to be appropriate SBRT candidate and scheduled to undergo SBRT as part of their care
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients with tumors < 1 cm
- •Patients with nodal disease or distant metastatic disease
- •Patients may not be receiving any other investigational agents
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients must not be pregnant
- •Patients with allergies to iodinated contrast not amenable to pre-medication
- •Patients who are not able to lie supine with arms raised, and cooperate with breathholding instructions
结局指标
主要结局
Change in blood flow (mL/min/100 g) as measured on perfusion CT
时间窗: Baseline to up to 3 months post SBRT
Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints.
Change in mean transit time (seconds) as measured on perfusion CT
时间窗: Baseline to up to 3 months post SBRT
Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints.
Change in permeability (mL/min/100 g) as measured on perfusion CT
时间窗: Baseline to up to 3 months post SBRT
Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints.
Change in blood volume (mL/100 g) as measured on perfusion CT
时间窗: Baseline to up to 3 months post SBRT
Descriptive statistics including mean and standard deviation or median and range, will be used to summarize the distribution of perfusion parameters (blood flow, blood volume, mean transit time and permeability), as well as their changes from baseline to the time-points after SBRT. Precision of the estimated means will be provided. Line graphs will be used to display the changes in the parameters over time. If the distribution of the data permits, mixed-effect linear regression analysis will be performed to examine the patterns of the pre- vs. post-SBRT change in the endpoints.
次要结局
- Clinical tumor response assessed by CT scans as determined by Response Evaluation Criteria in Solid Tumors criteria version 1.1(Up to 24 months post SBRT)