Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Acceptability of image quality of the novel cone-beam CT imaging system compared to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes
研究概览
简要总结
Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.
详细描述
This study is a prospective, non-randomized imaging evaluation study. A cohort of subjects undergoing standard of care radiation therapy will be selected based on malignancies from six disease sites. The Halcyon 4.0 images acquired in place of standard evaluation CT scans during the course of treatment will be used for target volume delineation and normal structures segmentation. Treatment plans will be recalculated based on the Halcyon 4.0 images from this system and compared to the original treatment plan. Dose differences will be evaluated. Two-tailed t-test will be used to compare the statistical significance of the dosimetric results as well as the volumetric differences among target volume and the volumes of organs at risk.
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
- •Subjects will be treated with external beam radiotherapy at the Perelman Center for Advanced Medicine for any of the following malignancies: head-and-neck, thoracic, breast, gastrointestinal, gynecologic, or genitourinary.
- •Age ≥ 18 years
- •Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
- •Availability of a complete set of treatment plans, including CT simulation images, target and normal structure contours, and radiation treatment prescriptions
排除标准
- •Subjects who are pregnant or have plans for pregnancy during the period of treatment.
- •Any malignancy not stated above.
- •Those unable to be treated on any linear accelerator (whether Truebeam™ or Halcyon™) unit either due to subject anatomy or treatment plan.
- •Those undergoing proton therapy.
结局指标
主要结局
Acceptability of image quality of the novel cone-beam CT imaging system compared to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes
时间窗: 1 year
Qualitative results (Yes is acceptable/No is not acceptable) will be reported as tabulated data to demonstrate the differences from the standard practice
Ease of use of the novel cone-beam CT imaging system compared to standard practice
时间窗: 1 year
Ease of use of the novel cone-beam CT imaging system on a scale of 1 (very easy to use, no difficulty) to 5 (unable to use due to difficulty)
Quantitative comparison of the image quality of the novel cone-beam CT imaging system to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes
时间窗: 1 year
A scale of Better/Worse/Equal will be used for metrics such as CBCT image artifact, CBCT image quality for OAR contouring, CBCT image quality for GTV contouring, motion artifacts, auto-segmentation ability, electron density similarity
Statistical significance of quantitative comparison of the image quality of the novel cone-beam CT imaging system and standard practice
时间窗: 1 year
For situations that the quantitative results will be measured, such as the structure volume or predicted electron densities etc., statistical significance will be calculated.
次要结局
- Evaluation of the suitability and workflow of the novel CBCT images for radiation treatment planning and dose calculation.(1 year)