Breath Combined With CT for Diagnoses of Pulmonary Nodules

Peking University

Status: Unknown

Conditions: Pulmonary Nodule, Multiple; Non-small Cell Lung Cancer

Treatments: Diagnostic Test: Breath test combined with computed tomography; Diagnostic Test: Pathological examinations as the golden diagnosis criteria

Study type: Observational

Funder types: Other

Identifiers

NCT04948047

2021PHB150-001

Details and patient eligibility

About

Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining breath test with chest computed tomography (CT). This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from exhaled breath and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be validated prospectively.

Full description

Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer. Pulmonary nodules diagnosis using breath test of volatile organic compound (VOC) is in its infancy. The accuracy of VOC analysis in diagnosing malignant pulmonary nodules varies cross the published studies. The diagnosis accuracy of VOC alone is generally poor. We speculate that the accuracy of diagnosing malignant pulmonary nodules will be improved by combining VOC analysis with chest computed tomography.

In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of patients with pulmonary nodules. The chest CT will be used for detecting the imaging characteristics of pulmonary nodules. The pathological diagnosis of pulmonary nodules after surgical resections is selected as golden standard.

This study aims to establish a predictive model of malignant pulmonary nodule using bio-markers from breath test and image-markers from chest CT with retrospective data from multi centers. The sensitivity, specificity and accuracy of the model will be varied prospectively.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years old;
2. Pulmonary nodules with planned surgical resection;
3. Signed informed consent and agreed to participate in this study.

Exclusion criteria

1. Preoperative radiotherapy, chemotherapy, targeted therapy or other anti-tumor therapy
2. The lack of chest computed tomography within two weeks before surgery
3. A history of malignant disease within 5 years.

Trial design

900 participants in 2 patient groups

Malignant pulmonary nodules

Description:

Patients with pulmonary nodule diagnosed as malignant cancer by pathological examinations after surgical resection.

Treatment:

Diagnostic Test: Pathological examinations as the golden diagnosis criteria

Diagnostic Test: Breath test combined with computed tomography

Benign pulmonary nodules

Description:

Patients with pulmonary nodule diagnosed as benign disease by pathological examinations after surgical resection.

Treatment:

Diagnostic Test: Pathological examinations as the golden diagnosis criteria

Diagnostic Test: Breath test combined with computed tomography