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Completed

NCT Number: NCT03426306

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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