Proof of Concept Study Evaluating Safety and Performance of a Gel Marker (BioXmark) Used for Image Guidance in Deep Inspiration Breathhold Radiotherapy (DIBH IGRT) in Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Visibility of the injected gel marker during the course of radiotherapy delivery
研究概览
简要总结
Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with locally advanced non-small cell lung cancer (NSCLC)
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 old
- •Histologically confirmed non-small cell lung cancer (NSCLC)
- •Stage T1-4N1-3M0
- •Performance status ≤ 2
- •Inoperable
- •FEV1 ≥ 1 l
- •Ability to hold deep inspiration breathhold for > 15 seconds
- •Accepting treatment at Rigshospitalet
- •Eligible for concomitant chemo-radiotherapy
- •If a woman is of childbearing potential, a negative pregnancy test must be documented
- •Ability to understand the given information
- •Signed written consent for inclusion into the study
排除标准
- •Prior thoracic radiotherapy
- •Allergy to Iodine or iodine based contrast
- •In the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons
研究组 & 干预措施
Treatment
干预措施: BioXmark (Device)
结局指标
主要结局
Visibility of the injected gel marker during the course of radiotherapy delivery
时间窗: 3 months
Stability of the geometrical configuration and visibility of the injected gel marker in 2D kV x-rays and CBCT (cone-beam computed tomography) acquired throughout the treatment course and quantified by vectors and contrast to noise ratio (CNR)
Number of pneumothoraxes in relation to placement procedure of the gel
时间窗: 0-1 week after placement of gel
Counting number of pneumothoraxes caused in relation to the placement procedure of the gel
次要结局
未报告次要终点
研究者
Steen Riisgaard Mortensen
MD
Rigshospitalet, Denmark