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

NCT03426306 | Completed DMC

• 1 other identifier: 17-2216.cc
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lung Cancer

Keywords

4-Dimensional Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ability of %PPO PFTs

  Start of study to end of study, up to 2 years

• Quality of Life (QOL)

  Start of study to end of study, up to 2 years

• Cost-Effectiveness

  Start of study to end of study, up to 2 years

• Longitudinal Imaging Changes

  Start of study to end of study, up to 2 years

Study Arms (1)

4DCT-ventilation

EXPERIMENTAL

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

Interventions

4DCT-Ventilation DIAGNOSTIC_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.

4DCT-ventilation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Patients getting a planned wedge resection as the only thoracic resectional procedure.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

UCHealth Memorial Hospital

Colorado Springs, Colorado, 80920, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bernard Jones

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 8, 2018
• Study Start: March 21, 2018
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)