MAGIK: Using Implanted Markers to Determine the Feasibility of Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging: A Phase I Interventional Study of Lung Cancer Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
研究概览
简要总结
This trial will investigate the feasibility of the Markerless Tumour Tracking technology.
详细描述
Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery to enable Markerless Tumour Tracking.
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
- •Is willing to comply with all trial procedures and intends to provide written Informed Consent for participation in this trial.
- •Patients undergoing external beam radiotherapy.
- •Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
- •MRI/4D-CT prior to insertion of fiducial markers.
- •Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
- •ECOG performance status 0-
- •A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
- •1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
- •The distance between the tumour centroid and the top end of the diaphragm is <=10 cm.
排除标准
- •Patient has low respiratory performance as evaluated by the physicians.
- •Previous high-dose thoracic radiotherapy.
- •Less than one fiducial marker implanted in the lung.
- •Fiducial markers are too far from the tumour centroid (>9 cm).
- •Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).
- •Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
- •Women who are pregnant or lactating.
- •Unwilling or unable to complete quality of life questionnaires.
研究组 & 干预措施
Markerless Image Guidance Arm
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
干预措施: Markerless Image Guidance (Device)
结局指标
主要结局
Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
时间窗: 2 years
This will be measured by 90% of the treatment fractions achieving: 1. Continuous on-line tracking with no software failure; 2. Agreement between markerless and marker-based tracking within 3 mm in each direction (left-right, superior-inferior, anterior-posterior) for at least 80% of the beam-on time as assessed in off-line analyses.
次要结局
未报告次要终点