4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- The overall correlation between the 4D-CT and the SPECT ventilation images.
Study Overview
Brief Summary
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Children (less than 18 years of age), pregnant women, Stanford employees or students, or prisoners will be excluded from this study.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: TECHNETIUM TC 99M MAA (Drug)
Outcomes
Primary Outcomes
The overall correlation between the 4D-CT and the SPECT ventilation images.
Time Frame: 24 months
Secondary Outcomes
- 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)
Investigators
Billy W. Loo Jr.
Associate Professor of Radiation Oncology
Stanford University