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Completed

NCT Number: NCT02843568

Improving Pulmonary Function Following Radiation Therapy

The purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to try to identify high functioning normal lung tissue.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Johnson Creek, Johnson Creek, Wisconsin, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic diagnosis of non-small cell lung cancer or lung metastasis from a solid tumor. One biopsy site is adequate for multiple sites of thoracic disease.
  • Treatment includes localized radiation therapy with or without chemotherapy
  • Karnofsky ≥ 60%
  • Not pregnant per radiation oncology standard procedures
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer
  • Prior thoracic radiotherapy
  • Severe COPD defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months
  • Oxygen dependence of > 2 L/min continuously throughout the day at baseline
  • Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Standard fractionation

Radiation

60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments

Other names: Cancer Radiotherapy, Radiation

Stereotactic Body Radiation Therapy (SBRT)

Radiation

40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments

Other names: SBRT, Cancer Radiotherapy, Radiation

Four Dimensional Computed Tomographic Imaging (4DCT)

Procedure

Subjects undergo a total of 7 research-ordered four dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning.

Other names: 4DCT

Primary outcomes

  1. Pulmonary Function, Based on Changes in Tissue Elasticity Measured From 4DCT

    Time frame: 3 months post RT

    The primary endpoint of this study will be the ratio of the tissue elasticity map following RT to the elasticity map before RT (i.e., the Jacobian ratio of (post RT /pre RT)) calculated from 4DCT at 3 months post-RT. Based on the randomness of our measurement technique, diminished expansion (i.e. substantial change) is defined as a Jacobian ratio <0.94 (i.e., less than 94% of the pre-RT value).

Secondary outcomes

  1. Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)

    Time frame: During therapy to 12 months post-RT

    Changes in Reduced Elasticity (defined as < 0.94*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.

  2. Temporal Changes in Reduced Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)

    Time frame: During therapy to 12 months post-RT

    Changes in Reduced Elasticity (defined as < 0.94*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.

  3. Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Percent Change)

    Time frame: During therapy to 12 months post-RT

    Changes in Increased Elasticity (defined as > 1.06*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.

  4. Temporal Changes in Increased Elasticity Determined by the Volume of Lung Where Expansion is Improved (Ratio)

    Time frame: During therapy to 12 months post-RT

    Changes in Increased Elasticity (defined as > 1.06*median) Determined by the Volume of Lung Where Expansion is Improved (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.

  5. Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Percent Change)

    Time frame: During therapy to 12 months post-RT

    Changes in Expansion of Lung Determined by the Volume of Lung Where "Meaningful" Expansion (defined as > 1.1*median ) Occurs (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.

  6. Temporal Changes in Fraction of Expanding Lung Determined by the Volume of Lung Where "Meaningful" Expansion Occurs (Ratio)

    Time frame: During therapy to 12 months post-RT

    Changes in Expansion of Lung Determined by the Volume of Lung Where "Meaningful" Expansion (defined as > 1.1*median ) Occurs (During therapy to 12 months post-RT). All statistical tests will be two-sided and assessed for significance at the 5% level.

  7. Median Absolute Change in the Percent Predicted for Pulmonary Function Tests (PFTs)

    Time frame: Pre-RT up to 12 months post-RT

    Median absolute change in the percent predicted following pulmonary function tests reported: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and diffusing capacity of carbon monoxide (DLCO). All statistical tests will be two-sided and assessed for significance at the 5% level.

  8. Validation in Consistency of Tissue Elasticity Changes Measured With Values Predicted Based on Existing Radiation Dose Response Curves

    Time frame: Up to 12 months post-RT

    All statistical tests will be two-sided and assessed for significance at the 5% level.

  9. Variation of the Tissue Elasticity Calculated Between Scan 1 and Scan 2 at Each Time Point Will be Quantified and Compared to Longitudinal Changes in Tissue Elasticity

    Time frame: Up to 12 months post-RT

    All statistical tests will be two-sided and assessed for significance at the 5% level.

Other outcomes

  1. Change in Blood Inflammation Markers

    Time frame: Baseline to 3 months following radiation

    All statistical tests will be two-sided and assessed for significance at the 5% level. Analysis is exploratory and compares pre-treatment versus post-treatment for the entire population.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Jul 26, 2016
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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