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

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

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01034514
Enrollment
35
Registered
2009-12-17
Start date
2009-12-31
Completion date
2014-06-24
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

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

Interventions

DEVICEReal-time Position Management system

Standard of Care

DEVICEDiscovery ST multislice PET/CT scanner

Standard of Care

DEVICEInfinia Hawkeye SPECT/CT gamma camera

Standard of Care

DEVICEPinnacle3 treatment planning system

Standard of Care

DEVICESKYLight nuclear camera

Standard of Care

DRUGDTPA

1 mCi; inhalation

DRUGTECHNETIUM TC 99M MAA

3 mCi; iv

Sponsors

Billy W. Loo Jr.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

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

Secondary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026