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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-06-24

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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Real-time Position Management system

Intervention Type DEVICE

Standard of Care

Discovery ST multislice PET/CT scanner

Intervention Type DEVICE

Standard of Care

Infinia Hawkeye SPECT/CT gamma camera

Intervention Type DEVICE

Standard of Care

Pinnacle3 treatment planning system

Intervention Type DEVICE

Standard of Care

SKYLight nuclear camera

Intervention Type DEVICE

Standard of Care

DTPA

Intervention Type DRUG

1 mCi; inhalation

TECHNETIUM TC 99M MAA

Intervention Type DRUG

3 mCi; iv

Interventions

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Real-time Position Management system

Standard of Care

Intervention Type DEVICE

Discovery ST multislice PET/CT scanner

Standard of Care

Intervention Type DEVICE

Infinia Hawkeye SPECT/CT gamma camera

Standard of Care

Intervention Type DEVICE

Pinnacle3 treatment planning system

Standard of Care

Intervention Type DEVICE

SKYLight nuclear camera

Standard of Care

Intervention Type DEVICE

DTPA

1 mCi; inhalation

Intervention Type DRUG

TECHNETIUM TC 99M MAA

3 mCi; iv

Intervention Type DRUG

Other Intervention Names

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RPM System Positron Emission Tomography Single-photon emission computed tomography Radiation Treatment Planning Philips Medical Systems DRAXIS Specialty Pharmaceuticals Inc. DRAXIS Specialty Pharmaceuticals Inc.

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.