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

Early Phase 1

Terminated

• Conditions: Lung Cancer
• Interventions: 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

• Registration Number: NCT01034514
• Lead Sponsor: Billy W. Loo Jr.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2014-06-24
• Study Completion: 2014-06-24
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4DCT arm	Discovery ST multislice PET/CT scanner	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.
4DCT arm	Infinia Hawkeye SPECT/CT gamma camera	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.
4DCT arm	Real-time Position Management system	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.
4DCT arm	DTPA	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.
4DCT arm	Pinnacle3 treatment planning system	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.
4DCT arm	SKYLight nuclear camera	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.
4DCT arm	TECHNETIUM TC 99M MAA	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.

Primary Outcome Measures

Name	Time	Method
The overall correlation between the 4D-CT and the SPECT ventilation images.	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States