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临床试验/NCT06409000
NCT06409000已完成不适用

3D Surface Scanning for Virtual-CT Based Radiation Therapy Treatment Planning

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
26
试验地点
2
主要终点
Dose distribution agreement between virtual and planning computed tomography (CT) datasets

研究概览

简要总结

This study evaluates if three dimensional (3D) surface images can be used instead of the standard computed tomography (CT) scans for treatment planning in electron radiation therapy. 3D scanning has previously been used by several groups to design patient-specific devices to be 3D printed, and as has shown excellent agreement with CT obtained surfaces. Using 3D surface imaging instead of x-ray based CT, benefits include: no ionizing radiation used to produce images, shorter time between patient consultation and treatment, and ability to produce and evaluate patient-specific devices for electron therapy earlier in the treatment planning process. This study may help researchers learn how 3D surface scanning may be used to produce a virtual CT image of patient surfaces, and accurately replace traditional planning CT for treatment planning of electron based radiation therapy.

详细描述

PRIMARY OBJECTIVES:

I. Develop and benchmark the necessary software to convert a 3D scan to a virtual CT.

II. Compare the spatial accuracy of virtual CTs from 3D scans to the planning CT.

III. Compare radiation treatment plans based on the virtual CTs from aim 2 to treatment plans based on the actual planning CTs.

OUTLINE: This is an observational study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Adults (18 years old or older)
  • Capable of consent
  • Receiving electron therapy and a planning CT scan
  • Consent to two 3D surface scans of treatment area

排除标准

  • Pediatric patients
  • Mentally incapable of study consent
  • Receiving electron radiation for a breast cancer boost
  • Receiving electrons for total skin electron therapy
  • Patients with epilepsy or other seizure disorders

研究组 & 干预措施

Observational (3D surface scans, medical records)

Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study.

干预措施: Electronic Health Record Review (Other)

Observational (3D surface scans, medical records)

Patients undergo 3D surface scans on study. Patient's medical records are also reviewed on study.

干预措施: Three-Dimensional Imaging (Procedure)

结局指标

主要结局

Dose distribution agreement between virtual and planning computed tomography (CT) datasets

时间窗: Up to 2 months

The various three dimensional (3D) scans and CTs of the phantoms will be qualitatively assessed for agreement and accuracy to determine best practice, but there will be no statistical significance tested for. Will be conducted entirely on inanimate, plastic, anthropomorphic models (phantoms).

Geometric agreement between virtual and planning CT datasets

时间窗: Up to 2 months

Will test for distance to agreement differences between 3D scans taken at different time points (consultation, simulation, and treatment).

Geometric agreement between 3D scans taken at different time points

时间窗: Up to 2 months

Various dose metrics will be extracted from each of the three types of dose distribution: the ground truth CT based dose distribution, the 3D scan based virtual CT dose distributions, and the flat water phantom based dose distributions. Paired statistical tests will be used for each metric to test for significant differences between the various methods used to calculate the dose distributions.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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