Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Measurement of gross tumor volume and involved lymph nodes
研究概览
简要总结
This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.
详细描述
PRIMARY OBJECTIVES:
I. Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).
II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.
OUTLINE:
Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to undergo MRI imaging; contrast application will be determined according to institutional guidelines; patients with lung cancer or locally recurrent lung cancer (following surgery) who are scheduled to receive external beam radiation therapy for at least 6 weeks
- •Tumor visible on planning CT scan
- •Negative pregnancy test for women of childbearing potential prior to study entry
排除标准
- •Patients requiring continuous supplemental oxygen
- •Patients with metal implants including pace makers and defibrillators
- •Patients with cerebral aneurysm clips or middle ear implant
- •Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
- •Claustrophobic patients
- •Prior radiotherapy to body area under investigation
- •No vulnerable populations will be enrolled (prisoners, children, pregnant females, or institutionalized individuals)
结局指标
主要结局
Measurement of gross tumor volume and involved lymph nodes
时间窗: Up to 3 months
A paired sample t-test could be applied to test the difference between MRI, CT, and PET-CT contours. Parameters used for comparison will include volume size, volume overlap, such as Dice similarity coefficients and Jaccard index, and surface distance maps including Hausdorff distance.
Spatial concordance of multimodality imaging for whole image registration
时间窗: Up to 3 months
A paired sample t-test will be used.
Change in functional response
时间窗: Baseline to 3 months
Patients will be classified into responders and non-responders based on their PET signal which will serve as the reference method for response assessment. Although this is a little different from the three group analysis of variance (ANOVA) used in the power calculation, it is expected that there will be similar high power when the partial responders and non-responders are combined. Receiver operating characteristic (ROC) analysis will be used to define a threshold of apparent diffusion coefficient (ADC) change to stratify between metabolic responders vs. non-responders.
Temporospatial registrations of radioresistant sub-volumes
时间窗: Up to 3 months
A paired sample t-test will be used. ROC analysis will be performed only for radioresistant sub-volumes to identify which diffusion weighted-MRI functional signal thresholds correlate with levels of tumor activity defined on PET.
次要结局
- Change in ADC(Baseline to 4 weeks)