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临床试验/NCT04070586
NCT04070586已完成不适用

ADAPT: Adaptive CT Acquisition for Personalised Thoracic Imaging: A Phase 1 Pilot Study on the Use of Respiratory Motion Guided 4DCBCT for Lung Cancer Radiotherapy

University of Sydney1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy

研究概览

简要总结

In this trial, Respiratory Motion Guided (RMG) 4DCBCT will be implemented for the first time on lung cancer patients. RMG-4DCBCT adapts the image acquisition as the patient's breathing changes (i.e. if the patient breathes faster, imaging data is acquired faster).

By adapting the acquisition to the dynamic patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.

详细描述

Four dimensional cone beam computed tomography (4DCBCT) continues to play a pivotal role in the safe delivery of radiotherapy treatments for lung cancer patients. 4DCBCT meets exacting tumour localisation requirements by allowing radiation therapists to measure the tumour as a patient breathes (4D=volumetric images plus respiratory induced tumour motion). Despite the success of 4DCBCT to date, it suffers from relatively poor image quality, very long scan times (4min) and higher imaging doses than are necessary. The primary reason for these problems is that although the purpose of 4DCBCT is to acquire information about tumour motion due to respiration, there is no feedback from the patients breathing signal to adapt and optimise the image acquisition process. This clinical trial is a phase 1 first in human's pilot study and the aim is therefore to prove feasibility of RMG-4DCBCT, not necessarily efficacy. As such, patient scans will be acquired across a broad range of patient breathing conditions to optimise the RMG-4DCBCT technique and also to plan a hypothesis driven clinical trial to follow.

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

  • Have the ability to give informed consent
  • A diagnosis of lung cancer with an indication for radiotherapy either curative or palliative
  • Radiotherapy treatment involving the routine acquisition of CBCT for patient setup provided that 4DCBCT is to be acquired during the course of treatment.
  • At least two radiotherapy fractions during the course of treatment.

排除标准

  • Pregnant women.
  • Patient who in the opinion of the treating physician could not tolerate the extra time on the treatment couch for two days of treatment.

结局指标

主要结局

RMG-4DCBCT image guidance is feasible for lung cancer patients undergoing radiotherapy

时间窗: 2 years

This will be achieved by performing (offline) analysis of the RMG-4DCBCT images obtained and scoring them on a scale of one (excellent quality for image guidance) to three (unsuitable for image guidance).

次要结局

  • To measure the extent of association between image quality and the patients' breathing conditions.(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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