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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer; Non Small Cell Lung Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Vitalite Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study participants in all cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria. This study will enroll 30 patients from 3 different cohorts (confirmed NSCLS, stable pulmonary nodules, screened and negative controls). Additionally, a second breath sample may be taken from the 30 patients with lung cancer, totalling up to 120 breath samples.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Confirmed Lung Cancer; To be eligible for the lung cancer group: Aged 50 and over;; Current or former smoker with smoking history ≥ 20 pack-years;; Capacity to give informed consent;; Non-metastatic non-small cell lung cancer, that has not been treated; No history of active cancer in the past 5 years (exceptions include: Ductal carcinoma in situ (DCIS), cervical intraepithelial neoplasia (CIN), non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6);; Able to provide a breath sample. To be eligible for a second breath sample: Same as above, in addition to, and with the exception of criterion 4:; Non-metastatic non-small cell lung cancer, which has undergone surgical resection;; 6 months since completion of surgery, radiation, and chemotherapy on primary NSCLC;; CT scan at least 6 months after surgical resection, confirming the absence of lung cancer.
Control; For a participant to be eligible in the study control group: Aged 50 and over;; Current or former smoker with smoking history ≥ 20 pack-years;; Capacity to give informed consent;; No history of active lung cancer;; No pulmonary nodule(s);; No active cancer in the last 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason ≤ 6 prostate cancer will be exceptions);; Ability to provide a breath sample.
Stable pulmonary nodule; For a participant to be eligible for admission to the stable lung nodules group: Aged 50 and over;; Current or former smoker with smoking history ≥ 20 pack-years;; Capacity to give informed consent;; No history of active lung cancer or other active cancer in the past 5 years; (Note: DCIS, CIN, non-invasive bladder cancer, non-melanoma skin cancers, Gleason prostate cancer ≤ 6 or lower will be exceptions);; Presence of one or more stable lung nodules (as determined by the principal investigator);; Ability to provide a breath sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Picomole Inc
• Collaborators: Vitalite Health Network
• Investigators: Study Director: Nada Hammami, Vitalite Health Network; Principal Investigator: Marcel Mallet, MD, Vitalite Health Network

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ROMEO 101712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No