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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: 4DCT-Ventilation

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Colorado Springs, Colorado, United States, 80920
      • UCHealth Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Bernard Jones, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: 4-Dimensional Computed Tomography
• Other Study ID Numbers: 17-2216.cc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No