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临床试验/NCT02503917
NCT02503917Unknown不适用

Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour

研究概览

简要总结

This study will establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images using both healthy volunteer and cervical patient cohorts. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

详细描述

Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.

Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

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
Female
接受健康志愿者

入选标准

  • healthy volunteer cohort: Healthy female adult volunteers
  • patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.

排除标准

  • both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study

结局指标

主要结局

Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour

时间窗: DSC calculated at 24 time points for each healthy volunteer (3 days)

The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.

Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT

时间窗: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy

A small COV will indicate greater clinician/expert confidence in segmenting the uterus

次要结局

  • Bland-Altman plot (healthy volunteer cohort)(1 day)
  • Uterine center of mass displacement on ultrasound (healthy volunteer cohort)(3 days)
  • Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)(from data collected over 3 days)
  • Bland-Altman plot (patient volunteer cohort)(6 weeks)
  • Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)(from data collected over 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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