A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
研究概览
简要总结
Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning
External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy
Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment
Primary objectives: To assess pre-treatment global and focal lung strain and correlate with changes post-treatment
详细描述
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using four dimensional CT (4D-CT) treatment planning scans. Patients with newly diagnosed lung cancer will be planned using 4D-CT to assess lung and tumor motion. Standard radiation treatment plans will to delivered based on tumor stage. Patients will be reassessed both clinically and radiographically using 4D-CT imaging at 3 months and 6 months post-treatment. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age >/= 18 years
- •ECOG performance status 0-1
- •Pathologic or clinical diagnosis of lung malignancy
- •Patients must have a reproducible tidal volume sufficient for 4D-CT imaging
- •Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- •Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- •Patients must provide study specific informed consent prior to study entry.
排除标准
- •Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
- •Pregnant women or lactating women
结局指标
主要结局
validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
时间窗: Pre-treatment (baseline) up to 6 months post-treatment
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.
次要结局
- correlate post-treatment strain with radiographic changes to the lung parenchyma(2 years post-treatment)
- correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.(2 years post treatment)
- correlate pre- and post-treatment strain with clinical toxicity(Pre-treatment (baseline) to 2 years post treatment)
研究者
Neal Edward Dunlap
Associate Professor
University of Louisville