A Pilot Study of Perfusion CT for Lung Tumors Treated With Stereotactic Ablative Radiation Therapy (SABR)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of participants able to complete perfusion scan acquisition at the time of treatment-planning
研究概览
简要总结
This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility of performing computed tomography (CT) perfusion imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care.
SECONDARY OBJECTIVES:
- To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
- To correlate perfusion parameters with tumor response 1 year post-SABR
OUTLINE:
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
- •Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases
排除标准
- •Patients who are pregnant or are trying to become pregnant are excluded from this study
- •Patients with renal failure, defined as glomerular filtration rate (GFR) < 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded
研究组 & 干预措施
Diagnostic (CT perfusion imaging)
Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent
干预措施: CAPP-Seq (Device)
Diagnostic (CT perfusion imaging)
Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent
干预措施: Isovue-200 (Drug)
Diagnostic (CT perfusion imaging)
Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent
干预措施: Computed Tomography Perfusion Imaging (Radiation)
结局指标
主要结局
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning
时间窗: Up to approximately 90 seconds
Number of participants able to complete perfusion scan acquisition within 48 hours of SABR
时间窗: Within 48 hours post-SABR
Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR
时间窗: Up to 4 months post-SABR
次要结局
- The calculated variance of mean transit time such that measurable changes can be identified in future studies(Baseline to up to 4 months post-SABR)
- The calculated variance of permeability such that measurable changes can be identified in future studies(Baseline to up to 4 months post-SABR)
- The calculated variance of blood flow such that measurable changes can be identified in future studies(Baseline to up to 4 months post-SABR)
- The calculated variance of blood volume such that measurable changes can be identified in future studies(Baseline to up to 4 months post-SABR)