Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer

Lung Cancer Clinical Trial

Official title:

Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288646
• Other study ID #: ROMEO 101712
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Picomole Inc
• Contact: Joanne Young
• Phone: 5068552400
• Email: joanne.young[@]breathebiomedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer. Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.

Description:

Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 15, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.

Exclusion Criteria:

• Patients are not eligible if they are currently receiving treatment for lung cancer.
• Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment. Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around

the equipment). We ask participants to refrain from:

• Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling;
• Consume alcohol (including mouthwash) at least 8 hours before breath sampling.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Canada	Vitalite Health Network	Moncton	New Brunswick

Sponsors (2)

Lead Sponsor	Collaborator
Picomole Inc	Vitalite Health Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls	Using infrared cavity-ringdown spectroscopy, breath spectra of volatile organic compounds (VOCs) will be measured. Breath spectra will be statistically analyzed to identify features specific to each of the respective cohorts. These features will be used to train mathematical and statistical models to differentiate and categorize the samples within the three cohorts.	2 years
Secondary	Differences in breath spectra of patients with lung cancer before and after treatment	Using infrared cavity ring-down spectrometry, breath samples will be taken from individual patients before and after surgical resection of the tumour. The objective is to identify and measure intra-patient differences in respiratory profiles before and after treatment.	2 years