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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03426306

Enrollment

Registered

2018-02-08

Start date

2018-03-21

Completion date

2022-01-18

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

4-Dimensional Computed Tomography

Brief summary

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

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.

Interventions

DIAGNOSTIC_TEST4DCT-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pre-Surgical Imaging and Post-Surgical Lung Function	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

Measure	Time frame	Description
Ability of %PPO PFTs	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)	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	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	Start of study to end of study, up to 2 years	Derive novel post-surgical prediction formulas using longitudinal 4DCT-ventilation imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026