Breath Combined With CT for Diagnoses of Pulmonary Nodules

Non-small Cell Lung Cancer Clinical Trial

Official title:

Assessment of the Efficacy of Breath Test Combined With Computed Tomography for Diagnoses of Pulmonary Nodules.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948047
• Other study ID #: 2021PHB150-001
• Status: Recruiting
• Start date: July 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: Mantang Qiu, PhD
• Phone: 13915973485
• Email: qiumantang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2022
• Est. primary completion date: October 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Non-small Cell Lung Cancer
• Pulmonary Nodule, Multiple

Intervention

Diagnostic Test:
• Pathological examinations as the golden diagnosis criteria
Pathological diagnosis, as the golden standard for diagnosing pulmonary nodules, is achieved by two experienced pathologists and validated by the third senior pathologist.
• Breath test combined with computed tomography
Exhaled breath of each participant will be collected with Tedlar bags. The volatile organic compounds will be detected by a high-resolution high-pressure photon ionization time-of-?ight mass spectrometry (HPPI-TOFMS). The Imaging markers of pulmonary nodules, including the size, three-dimensional shape, and appearance characteristics, are derived from the chest computed tomography within 2 weeks before surgery resection.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Breatha Biological Technology Co., Ltd, Beijing, Beijing Haidian Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity of breath test combined with computed tomography	Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated	8 weeks
Primary	Diagnostic specificity of breath test combined with computed tomography	Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic specificity of breath test combined with computed tomography will be calculated	8 weeks
Primary	Diagnostic accuracy of breath test combined with computed tomography	Using pathological diagnosis of pulmonary nodule as gold standard, diagnostic accuracy of breath test combined with computed tomography will be calculated	8 weeks
Secondary	Positive predictive value of breath test combined with computed tomography	Using pathological diagnosis of pulmonary nodule as gold standard, positive predictive value of breath test combined with computed tomography will be calculated	8 weeks
Secondary	Negative predictive value of breath test combined with computed tomography	Using pathological diagnosis of pulmonary nodule as gold standard, negative predictive value of breath test combined with computed tomography will be calculated	8 weeks