Pilot Study of Dual-Energy Computed Tomography in Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT.
研究概览
简要总结
Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer.
- •Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
- •PET-CT study within 4 weeks of next available DECT study.
- •Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
- •Kidney function sufficient to tolerate iodine-based CT contrast.
- •No allergy to iodine-based contrast.
- •Ability to understand and the willingness to sign informed consent.
排除标准
- •Participants with a prior history of thoracic radiotherapy.
- •Participants may not be receiving any other study agents.
- •Inability to tolerate CT contrast
- •Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.
结局指标
主要结局
Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT.
时间窗: 0, 1, 3, 5
This change in the maximum IRA will be compared with the change in the maximum standardized uptake value (SUV max) between baseline PET-CT and follow-up PET-CT at 3 months after treatment. For patients undergoing surgery, this change in the maximum IRA will be compared between patients who have a complete pathologic response, and those patients who do not.
次要结局
未报告次要终点