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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426306
Recruitment Status : Active, not recruiting
First Posted : February 8, 2018
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.

Condition or disease Intervention/treatment Phase
Lung Cancer Diagnostic Test: 4DCT-Ventilation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Novel Lung Function Imaging Modality as a Preoperative Evaluation Tool (LIME)
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : December 14, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pre-Surgical Imaging and Post-Surgical Lung Function [ Time Frame: 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 :
  1. Ability of %PPO PFTs [ Time Frame: 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

  2. Quality of Life (QOL) [ Time Frame: 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.

  3. Cost-Effectiveness [ Time Frame: 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.

  4. Longitudinal Imaging Changes [ Time Frame: Start of study to end of study, up to 2 years ]
    Derive novel post-surgical prediction formulas using longitudinal 4DCT-ventilation imaging


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426306


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
UCHealth Memorial Hospital
Colorado Springs, Colorado, United States, 80920
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Bernard Jones University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03426306    
Other Study ID Numbers: 17-2216.cc
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
4-Dimensional Computed Tomography