Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants who demonstrate significant motion movement during radiation therapy.
研究概览
简要总结
Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). A patient-specific 4D model will be developed using the raw 4DCT projections time-correlated with real-time surface monitoring. In addition, before delivering each dose fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions, time-correlated with optical surface monitoring. The acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.
详细描述
Surface monitoring procedure -The procedure is expected to last approximately 15 minutes after the end of the 4DCT scan, which is the standard-of-care for lung SBRT treatments at our institution. The procedure will consist of real-time surface tracking using the VisionRT system of the thoracic and/or abdominal region. Continuous audiovisual contact will be maintained with the subject during scanning. Each individual will be informed that they can stop the procedure at any point.
Fluoroscopic imaging procedure - Fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. Three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kV imager. Audiovisual contact will be maintained at all times with the patient.
Data collection and management: An ID number will be assigned to each separate patient, and the correlation between ID number and patient name and medical record number will be kept in a password-protected file in Dr. Amit Sawant's office. The database of information extracted from the medical record and radiation treatment records for each patient will be stored in an Excel file on a computer with password protection. All image data will be de-identified by Dr. Sawant before his research team analyzes them.
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
- •Eligible disease(s)/stage(s) - Patients with primary or metastatic lung lesions to be treated using stereotactic body radiotherapy (SBRT) will be eligible for this study.
- •Allowable type and amount of prior therapy - Any types and amounts of prior therapy will be allowed for this study.
- •Age restriction and/or gender/ethnic restrictions - Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
- •Life expectancy restrictions - None.
- •ECOG or Karnofsky Performance Status - Karnofsky performance status of 50 or greater
- •Requirements for organ and marrow function - None.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Tumor motion > 5 mm, maximum GTV dimension < 50 mm - per guidelines established by the AAPM Task Group 7612 and RTOG 0236.13
排除标准
- •Children (age <18)
- •Women who are pregnant or trying to get pregnant
- •Pain in supine position
- •Karnofsky performance status < 50
结局指标
主要结局
Number of participants who demonstrate significant motion movement during radiation therapy.
时间窗: 1.5 years
Develop novel Four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.
次要结局
未报告次要终点
研究者
Department of Radiation Oncology
Principal Investigator
University of Maryland, Baltimore