Protoacoustic Imaging for 3D Mapping the Bragg Peak in Real Time During Proton Therapy (PROTEUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of Liver Cancer Patients With Successful Respiratory Motion From Radiacoustic Imaging Tracking.
研究概览
简要总结
The purpose of this study is to test a new imaging technology called radioacoustic imaging (RAI) that may help doctors see where radiation is being delivered during proton therapy.
During proton therapy, the radiation treatment produces very small sound signals inside the body. This study will use special ultrasound sensors placed on the outside of the body to detect these signals. The information collected may allow researchers to create a picture showing where the radiation dose is being delivered in the body and how much radiation is reaching the treatment area.
The goal is to determine whether this technology can safely and accurately measure radiation during proton therapy without requiring any additional procedures or radiation exposure.
详细描述
Radiation therapy is a cornerstone of cancer treatment, and proton therapy offers enhanced precision for treating deep-seated tumors due to the Bragg Peak phenomenon, which allows for concentrated dose delivery while minimizing exposure to surrounding healthy tissue. This study seeks to build upon this advantage by incorporating real-time, in vivo verification of proton dose deposition. The study hypothesizes that integrating RAI with ultrasound (US) will enable real-time dose verification and motion tracking, thereby improving the accuracy, adaptability, and overall effectiveness of proton therapy for moving targets such as the liver and prostate.
Participants enrolled in the study will first undergo standard X-ray alignment as part of their routine treatment workflow. Following alignment, a robotic arm will position an ultrasound matrix array over the lower anterior abdominal region. A conformal, water-mediated interface in combination with ultrasound gel will be used to ensure optimal acoustic coupling between the transducer and the patient's skin, allowing for passive detection of acoustic signals generated during proton beam delivery. These signals will be used to reconstruct and monitor dose deposition in real time throughout treatment.
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
- 否
入选标准
- •Patients at least >18years old
- •Patients referred to OUHSC SCC for SOC PT
- •Patients receiving treatment for indications where RAI data collection is feasible (e.g., liver and prostate)
- •Willingness and ability to provide a documented informed consent
排除标准
- •Patients with contraindications for ultrasound coupling (e.g., extensive open wounds or skin conditions at transducer placement sites).
- •Patients whose treatment plan or setup prevents the practical application of the RAI system without interfering with standard clinical care
- •Patients with implanted electronic devices (e.g., pacemakers) in the treatment region if there is any concern of device interference, even though the RAI system is passive.
研究组 & 干预措施
Proton Therapy In Vivo
This prospective clinical trial will evaluate the use of RAI in 24 cancer patients, including 12 patients with liver cancer and 12 patients with prostate cancer, using a noninvasive device. The device consists of a small ultrasound transducer placed on the participant's body that delivers low-intensity sound signals through the body to evaluate the treatment.
干预措施: Radiacoustic Imaging w/Ultrasound. (Device)
结局指标
主要结局
Percentage of Liver Cancer Patients With Successful Respiratory Motion From Radiacoustic Imaging Tracking.
时间窗: 1 year
The dual-modality Radioacoustic Imaging integrated with Ultrasound (RAI/US) system in liver cancer patients is deployed to track respiratory motion, overlay real-time dose maps on ultrasound anatomy, and integrate adaptive feedback into the treatment workflow.
次要结局
- Percentage of Completed Workflow Treatment Plans Using Radiacoustic Imaging With Ultrasound In Prostate Cancer Patients.(1 year)