Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments real-time position management system, discovery st multislice pet/ct scanner, infinia hawkeye spect/ct gamma camera, pinnacle3 treatment planning system, skylight nuclear camera, dtpa, technetium tc 99m maa
Sponsor Stanford University
Start date December 2009
End date December 2016
Trial size 30 participants
Trial identifier NCT01034514, LUN0034, SU-04232009-2382

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
The overall correlation between the 4D-CT and the SPECT ventilation images.
time frame: 24 months

Secondary Outcomes

Measure
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.
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
Principal investigator Billy Loo
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Stanford University.