A Novel Lung Function Imaging Modality as a Preoperative Evaluation Tool (LIME)
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|ClinicalTrials.gov Identifier: NCT03426306|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2018
Last Update Posted : January 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Diagnostic Test: 4DCT-Ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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
- 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.
- 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.
- 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
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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|
- 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.
1. Patients getting a planned wedge resection as the only thoracic resectional procedure.
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
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|UCHealth Memorial Hospital|
|Colorado Springs, Colorado, United States, 80920|
|Principal Investigator:||Bernard Jones||University of Colorado, Denver|
|Responsible Party:||University of Colorado, Denver|
|Other Study ID Numbers:||
|First Posted:||February 8, 2018 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
4-Dimensional Computed Tomography