Respiratory Adaptive Computed Tomography: A Pilot Feasibility Study on the Use of Real-Time Gated 4DCT for Lung Cancer Radiation Therapy
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
- The feasibility of using Real-Time Gated 4DCT instead of Conventional 4DCT for planning radiotherapy for lung cancer.
研究概览
简要总结
This study does not involve a therapeutic intervention as standard radiation therapy treatment will be prescribed. This study involves one additional 4DCT scan (i.e. the Real-Time Gated 4DCT scan) acquired immediately before or following the conventional 4DCT scan. This will take place on the day of the patient's treatment simulation, as per the current standard of care. The scanning sequence (i.e. conventional first versus gated first) will be randomised.
The Real-Time Gated 4DCT is anticipated to take longer than the conventional 4DCT scan, due to its gated (beam-pause) nature. However, upper limits for timing will be implemented in the software, and the scan aborted for highly erratic breathing traces that would not benefit from a Real-Time Gated 4DCT scan.
详细描述
Four-dimensional computed tomography (4DCT) is considered the standard of care for modern high-precision stereotactic ablative body radiotherapy (SABR) techniques. Clinical 4DCT works by acquiring CT slices and breathing data synchronously as the patient moves through the rotating X-ray imager. The CT slices are sorted into 5-10 'phase images' (mid-exhale, peak-exhale, mid-inhale, peak-inhale, etc.) and stitched together to form a 3D+breathing induced tumour/organ motion or '4D' representation of the breathing anatomy. Current best practice in radiation therapy is for clinicians to perform manual delineation or 'contouring' of lung tumours on one or more 4DCT phase images to ensure proper coverage by the treatment beam despite breathing motion. In the presence of irregular breathing, mismatches arise between CT slices that are in the same breathing phase but imaged at different couch positions. As a result, the images produced suffer from various kinds of discontinuities including truncation, duplication or overlap. Yamamoto found that irregular breathing caused at least one error >4mm in 90% (45 out of 50) abdominal and thoracic patient scans. The main consequence of 4DCT image errors is that they can introduce tumour volume and position uncertainties as large as 30% between different 4D phase bins or different observers.
This can potentially reduce the likelihood of tumour control by up to one-third and lead to unnecessary irradiation of healthy lung tissue, contributing to major dose-limiting side effects like radiation pneumonitis, which is symptomatic in up to 30% of patients and fatal in 2%. The proposed solution is Real-Time Gated 4DCT using prospective regularity gating, which will be implemented for the first time on lung cancer patients.
The Real-Time Gated 4DCT method detects and then pauses the CT beam during irregular breathing events. We will analyse the patient's breathing pattern to prospectively gate acquisition in real-time. Real-time gated 4DCT ensures that the X-ray imager is switched on only when the breathing is regular; the scan gets paused otherwise. The benefits for the patient of gating a 4DCT scan have been demonstrated in previous studies:
- a reduction of breathing motion errors by 50%
- a reduction of imaging dose. Delineation of tumours and organs in CT scans is the first step in a lung cancer patient's radiation therapy journey. Accurate delineation is pivotal to patient outcomes because errors propagate throughout treatment and can lead to radiation dose missing parts of the tumour or unnecessarily irradiating healthy tissue or organs. Unfortunately, the most important imaging modality used for the delineation of lung cancers, 4DCT, is error prone. Radiation Oncologists (ROs) are faced with an enormous challenge and are required to delineate tumours when 90% of clinical scans suffer severe imaging errors. These errors obfuscate the true tumour position/shape and reduce the chance of tumour control by up to one third.
The main culprit for imaging errors is irregular breathing: i.e. natural breathing variations, which are heightened for lung cancer patients but not accounted for by clinical scanners. A solution to this problem was proposed, which is to gate the CT scanner (i.e. pausing the beam) whenever a breathing condition occurs that is likely to produce an imaging artefact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years or older
- •Have the ability to give informed consent
- •A diagnosis of lung cancer with an indication for radiation therapy
- •Radiation therapy treatment involving the acquisition of a 4DCT scan for treatment planning
排除标准
- •Pregnant women
- •Patients <18 years
- •Patients who in the opinion of the treating physician could not tolerate the extra time on the CT couch for an extra scan
研究组 & 干预措施
Real-Time Gated 4DCT and Conventional 4DCT
During the simulation (radiotherapy planning) session, the participant will undergo both the experimental 'Real-Time Gated 4DCT' and standard 'Conventional 4DCT'.
干预措施: Real-time Gated 4DCT (Diagnostic Test)
Real-Time Gated 4DCT and Conventional 4DCT
During the simulation (radiotherapy planning) session, the participant will undergo both the experimental 'Real-Time Gated 4DCT' and standard 'Conventional 4DCT'.
干预措施: Conventional 4DCT (Diagnostic Test)
结局指标
主要结局
The feasibility of using Real-Time Gated 4DCT instead of Conventional 4DCT for planning radiotherapy for lung cancer.
时间窗: 30 minutes
A change in the anticipated rate of image artifacts in images acquired from Conventional of 60% to 35% or less in images acquired from Real-Time Gated 4DCT.
次要结局
- Patient tolerance to the experimental scan (Real-Time Gated 4DCT)(1 minute at end of planning session)
- clinician confidence in acquiring a Real-Time Gated 4DCT scan(5 minutes at end of planning session)
- Effect on Real-Time Gated 4DCT image quality of patient characteristics: breathing type, breathing period, BMI, tumour location, breathing amplitude, breathing regularity, pulmonary function, ECOG status.(40 minutes, prior to and during the planning session)
- Difference in scanning time between Real-Time Gated 4DCT compared with Conventional 4DCT for planning of radiotherapy for lung cancer(30 minutes)
- clinician confidence in delineation on a Real-Time Gated 4DCT scan(5-10 minutes, following delineation of standard care and study scans.)
- Quality of treatment plan using images acquired during Real-Time Gated 4DCT compared with images acquired during Conventional 4DCT(1 week)
