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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: 4DCT-Ventilation

• Registration Number: NCT03426306
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Study Start: 2018-03-21
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4DCT-ventilation	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.

Primary Outcome Measures

Name	Time	Method
Pre-Surgical Imaging and Post-Surgical Lung Function	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 Outcome Measures

Name	Time	Method
Ability of %PPO PFTs	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)	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	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	Start of study to end of study, up to 2 years	Derive novel post-surgical prediction formulas using longitudinal 4DCT-ventilation imaging

Trial Locations

Locations (2)

UCHealth Memorial Hospital; 🇺🇸 Colorado Springs, Colorado, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States