Validation of Markerless Image Guidance Using Intrafraction Kolovoltage X-ray Imaging Using Implanted Fiducials: Phase I Observational Study of Lung Cancer Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Markerless Tumour Tracking
研究概览
简要总结
In radiotherapy, tumour tracking allows us to ensure the radiation beam is accurately targeting the tumour while it moves in a complex and unpredictable way. Most tumour tracking techniques require the implantation of fiducial markers around the tumour. Markerless Tumour Tracking negates the need for implanted markers, enabling accurate and optimal cancer radiotherapy in a non-invasive way.
详细描述
We will perform a phase I observational trial investigating the feasibility of the Markerless Tumour Tracking technology. Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients are 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 and used to calculate online Markerless Tumour Tracking. Markerless Tumour Tracking determines the mean tumour position calculated over the most recent 15 seconds and displays shifts exceeding 3 mm.
The trial will be a single-institution study recruiting only at RNSH Radiation Oncology Department.
As this trial investigates feasibility, our focus will be on estimating the proportion of treatment time in which the Markerless Tumour Tracking is within acceptable limits.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older.
- •Has provided written Informed Consent for participation in this trial and is willing to comply with the study.
- •Patients undergoing external beam radiotherapy.
- •Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
- •Diagnostic 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 <=8 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, concurrently with treatment or 7 days after radiotherapy.
- •Women who are pregnant or lactating.
- •Unwilling or unable to give informed consent.
- •Unwilling or unable to complete quality of life questionnaires.
研究组 & 干预措施
Markerless
Markerless Tumour Tracking will be used to observe the radiation beam is accurately targeting the tumour.
干预措施: Markerless Tumour Tracking (Radiation)
结局指标
主要结局
Markerless Tumour Tracking
时间窗: 6 months after recruitment
to demonstrate the feasibility of Markerless Tumour Tracking for motion-adaptive lung cancer radiotherapy as assessed by agreement between markerless and marker-based tracking within 3 mm for at least 80% of the beam-on time as assessed in off-line analyses.
次要结局
- Accuracy(6 months after treatment of last fraction)
- Markerless Tumour Tracking outcome(6 months after treatment of last fraction)
- Correlation(6 months after treatment of last fraction)
- Radiomic Features(6 months after treatment of last fraction)
- X-ray dose(6 months after treatment of last fraction)
- Magnitude(6 months after treatment of last fraction)
- Suitability(6 months after treatment of last fraction)
- Feasibility of outcomes prediction(6 months after treatment of last fraction)
- Outcomes(6 months after treatment of last fraction)
- Ineligibility(6 months after treatment of last fraction)
- Frequency(6 months after treatment of last fraction)
- Historical(6 months after treatment of last fraction)
研究者
Dasantha Jayamanne
Radiation Oncologist
Royal North Shore Hospital