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

University of Colorado, Denver65 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

4DCT-VentilationDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (2)

University of Colorado Denver

Aurora, Colorado, United States

UCHealth Memorial Hospital

Colorado Springs, Colorado, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline visit to follow up visit, up to 9 months.

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Start of study to end of study, up to 2 years

Data from ClinicalTrials.gov

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