NCT06576908已完成不适用
Evaluation of Image Quality From an On-Couch, Cone Beam Computed Tomography (CBCT) Radiation Treatment System for Image Guidance and Treatment Adaptation
Varian, a Siemens Healthineers Company2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年10月17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
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Comparison of overall free-breathing image quality: HyperSight CBCT vs Conventional CBCT
研究概览
简要总结
This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology (HyperSight) in patients receiving radiation treatment for cancer on a C-arm linear accelerator (TrueBeam).
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
- •Patient age is ≥ 18 years old.
- •Patient has a diagnosis of primary or metastatic cancer, including but not limited to tumors arising from or involving the head/neck, lungs, liver, pancreas, prostate, urinary bladder, rectum, cervix or uterus.
- •A previous (standard-of-care) decision was made to treat the patient with radiation therapy using a Varian TrueBeam treatment system.
- •A previous (standard-of-care) decision was made to treat the patient with a radiation dose of at least 20 Gy in at least 5 fractions, one fraction per day on consecutive days, Monday to Friday.
- •Patient is willing and able to provide informed consent to participate in the study.
排除标准
- •Patient is pregnant or has plans for pregnancy during the period of treatment.
- •Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").
研究组 & 干预措施
HyperSight Imaging arm
Experimental
Subjects have both HyperSight and conventional CBCT imaging.
干预措施: HyperSight Imaging (Device)
结局指标
主要结局
Comparison of overall free-breathing image quality: HyperSight CBCT vs Conventional CBCT
时间窗: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).
Semi-quantitative scoring (5-point Likert scale) of on-treatment, free-breathing HyperSight-TrueBeam CBCT images compared to on-treatment, free-breathing conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images.
次要结局
- Comparison of metal artifacts: HyperSight CBCT vs. Conventional CBCT(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Comparison of overall breath hold image quality: HyperSight CBCT vs Conventional CBCT(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Comparison of Hounsfield Unit accuracy: HyperSight CBCT vs Conventional CBCT and CT Simulation images(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Comparison of motion artifacts: HyperSight CBCT vs. Conventional CBCT(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Comparison of overall image quality: HyperSight CBCT vs Computed Tomography (CT) simulation images(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Breath hold imaging time(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Patient's perspectives of on-treatment HyperSight-TrueBeam CBCT(Day 1 of radiation treatment and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
- Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging.(Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).)
研究者
研究点 (2)
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