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临床试验/NCT04928755
NCT04928755Unknown不适用

Design and Evaluation of a Novel Methodology for Stereotactic Ablative Radiotherapy for Lung Cancer: Reducing Treatment Side-effects and Enabling More Patients to Benefit From This Treatment

Royal Surrey County Hospital NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2021年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Design a methodology that ensures tumour dose coverage is obtained when using the new treatment approach.

研究概览

简要总结

Aims: To increase the number of patients that benefit from Stereotactic Ablative Radiotherapy (SABR) for lung cancer using new treatment methods that reduce the amount of non-cancer tissue receiving a high radiation dose without affecting tumour dose coverage.

Background: SABR is a treatment for lung cancer which offers major advantages over conventional radiotherapy. It is a more precise highly effective treatment with significantly improved treatment outcomes (greater elimination of cancer cells).

SABR requires high doses per treatment so extreme accuracy is required to minimise healthy tissue damage. Normal breathing results in significant tumour movement, therefore to avoid missing the tumour, larger volumes need to be treated, resulting in more good tissue damage.

UK Standard practice requires the tumour to be irradiated in all positions during breathing whilst the new approach targets the tumours at the position it spends most time to minimise normal tissue affected by radiation.

Current practice for SABR patients would be improved (fewer severe radiation side-effects) and potentially could become a viable treatment for high risk patients.

Methods: 30 SABR patients receiving current standard SABR treatment will be recruited. This is an observation study in which patients will continue to receive standard of care but in addition:

  • A camera will be used to make videos of how the patient's chest moves in 3D at CT and treatment. I will build a complex mathematical model that infers movement of the tumour from movement of the chest.
  • Their breathing patterns, corresponding tumour motions and treatments plans will be utilised to develop a method for safely implementing the new treatment approach.

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

入选标准

  • All patients eligible for and who have consented to receive Lung SABR at the Royal Surrey County Hospital will be eligible for entry into this study.
  • Over 18 years old (radiotherapy is not delivered to 16-18yr olds at RSFT). No upper age limit.

排除标准

  • Patients with irregular breathing motion resulting in failed 4DCT
  • Patients with unusual chest surface deformities
  • Patients who lack the capacity to consent
  • Patients unable to read and communicate in English

结局指标

主要结局

Design a methodology that ensures tumour dose coverage is obtained when using the new treatment approach.

时间窗: 2 years

次要结局

  • Use a novel markerless non-contact approach (Microsoft Kinect) to create a model to correlate external respiratory motion with internal tumour motion.(2years)
  • Validate and refine correlation between predicted tumour motion and actual breathing motion.(2years)

研究者

发起方
Royal Surrey County Hospital NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

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