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

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

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: 4DCT-Ventilation


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4DCT-ventilation<br>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. | Diagnostic Test: 4DCT-Ventilation<br>* 4DCT-ventilation is an imaging modality that provides superior image quality, reduced cost, and a faster imaging procedure compared to nuclear medicine VQ scans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Surgical Imaging and Post-Surgical Lung Function | 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). | Baseline visit to follow up visit, up to 9 months. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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4-Dimensional Computed Tomography