4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

Study Overview
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Brief Summary
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To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.

Official Title
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4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Real-time Position Management system
* Device: Discovery ST multislice PET/CT scanner
* Device: Infinia Hawkeye SPECT/CT gamma camera
* Device: Pinnacle3 treatment planning system
* Device: SKYLight nuclear camera
* Drug: DTPA
* Drug: TECHNETIUM TC 99M MAA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4DCT arm<br>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. | Device: Real-time Position Management system<br>* Standard of Care<br>* Other names: RPM System;Device: Discovery ST multislice PET/CT scanner<br>* Standard of Care<br>* Other names: Positron Emission Tomography;Device: Infinia Hawkeye SPECT/CT gamma camera<br>* Standard of Care<br>* Other names: Single-photon emission computed tomography;Device: Pinnacle3 treatment planning system<br>* Standard of Care<br>* Other names: Radiation Treatment Planning;Device: SKYLight nuclear camera<br>* Standard of Care<br>* Other names: Philips Medical Systems;Drug: DTPA<br>* 1 mCi; inhalation<br>* Other names: DRAXIS Specialty Pharmaceuticals Inc.;Drug: TECHNETIUM TC 99M MAA<br>* 3 mCi; iv<br>* Other names: DRAXIS Specialty Pharmaceuticals Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall correlation between the 4D-CT and the SPECT ventilation images. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |