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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03426306
• Other study ID #: 17-2216.cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: January 31, 2025
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	UCHealth Memorial Hospital	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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