A Novel Lung Function Imaging Modality as a Preoperative Evaluation Tool (LIME)

Overview

To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 18, 2022

Detailed Description

To evaluate the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT-ventilation) imaging and post-surgical lung function. To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (PFTs). To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (QOL) questionnaires. Evaluate cost-effectiveness of using 4DCT-ventialtion and VQ scans for pre-surgical assessment. To use longitudinal (pre and post-surgical) 4DCT-ventilation imaging to derive novel post-surgical prediction formulas.

Interventions

  • Diagnostic Test: 4DCT-Ventilation
    • 4DCT-ventilation is an imaging modality that provides superior image quality, reduced cost, and a faster imaging procedure compared to nuclear medicine VQ scans.

Arms, Groups and Cohorts

  • Experimental: 4DCT-ventilation
    • The patient will undergo 4DCT imaging. The 4DCT imaging data along with image processing techniques will be used to generate a 4DCT-ventilation map. All surgical decisions will be based on the current standard of care imaging (VQ scans) and not on the 4DCT imaging results.

Clinical Trial Outcome Measures

Primary Measures

  • Pre-Surgical Imaging and Post-Surgical Lung Function
    • Time Frame: Baseline visit to follow up visit, up to 9 months.
    • Measure the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT) imaging and post surgical lung function using a Percent Predicted Post-Operative Pulmonary Function Test (%PPO PFT).

Secondary Measures

  • Ability of %PPO PFTs
    • Time Frame: Start of study to end of study, up to 2 years
    • Use %PPO PFTs to determine if 4DCT-ventilation is a better predictor of post surgical lung function than nuclear medicine imaging
  • Quality of Life (QOL)
    • Time Frame: Start of study to end of study, up to 2 years
    • Use QOL questionnaires to determine if 4DCT-ventilation is a better predictor of post surgical lung function than nuclear medicine imaging.
  • Cost-Effectiveness
    • Time Frame: Start of study to end of study, up to 2 years
    • Determine the cost-effectiveness of 4DCT-ventialtion and VQ scans for pre-surgical assessment using Receiver Operator Characteristic (ROC) analysis.
  • Longitudinal Imaging Changes
    • Time Frame: Start of study to end of study, up to 2 years
    • Derive novel post-surgical prediction formulas using longitudinal 4DCT-ventilation imaging

Participating in This Clinical Trial

Inclusion Criteria

1. Provision to sign and date the consent form. 2. Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study. 3. Be a male or female aged 18 to 100. 4. Patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection. 5. Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon. 6. Life expectancy greater than 3 months. Exclusion Criteria:

1. Patients getting a planned wedge resection as the only thoracic resectional procedure.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bernard Jones, Principal Investigator, University of Colorado, Denver

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