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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Lung Cancer

Treatments: Diagnostic Test: 4DCT-Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03426306

17-2216.cc

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

4DCT-ventilation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 4DCT-Ventilation