4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The overall correlation between the 4D-CT and the SPECT ventilation images.
研究概览
简要总结
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study. Note that we will carefully consider the inclusion of cases with turbulent flow or greater flow velocities (Cabahug et al., 1996; Crawford et al., 1990) and COPD cases (Magnant et al., 2006) due to the impaction of aerosol particles in central airways.
- •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
- •Not employed. Note that patients will need to be sufficiently healthy to undergo audiovisual (AV) biofeedback to generate high quality 4D-CT images.
- •Requirements for organ and marrow function None.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Children (less than 18 years of age), pregnant women, Stanford employees or students, or prisoners will be excluded from this study.
研究组 & 干预措施
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: Real-time Position Management system (Device)
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: Discovery ST multislice PET/CT scanner (Device)
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: Infinia Hawkeye SPECT/CT gamma camera (Device)
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: Pinnacle3 treatment planning system (Device)
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: SKYLight nuclear camera (Device)
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: DTPA (Drug)
4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
干预措施: TECHNETIUM TC 99M MAA (Drug)
结局指标
主要结局
The overall correlation between the 4D-CT and the SPECT ventilation images.
时间窗: 24 months
次要结局
- The difference between the local ventilation at simulation and during the treatment. Dose-volume or functional dose-volume metrics. The regression coefficient between the regional ventilation and time. The mean dose to the high-functional lung region.(24 months)
研究者
Billy W. Loo Jr.
Associate Professor of Radiation Oncology
Stanford University