Identifying Patterns in the Breath of Individuals With Breast Cancer

Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06512350

Enrollment

5175

Registered

2024-07-22

Start date

2025-02-25

Completion date

2028-02-01

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Infrared Spectroscopy, Machine Learning

Brief summary

Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection. Women with mammogram-confirmed breast tissue density undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results. The primary goal of this project is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's cavity ring-down spectrometer to further develop Breathe BioMedical's technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women aged 40 to 74. Secondarily, this project aims to identify patterns of VOCs that are either over- or under-represented in participants with breast cancer when compared to the breath profiles of participants without breast cancer. This project will also assess performance characteristics of the technology (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This project aims to understand intra-subject variability by exploring differences in breath signatures before and after definitive management of breast cancer, including surgical resection.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 74 Years

Healthy volunteers

Yes

Inclusion criteria

* Female (sex as assigned at birth); * Aged 40 - 74 years; * Mammography confirmed breast tissue density (BI-RADS density score of A, B, C or D); * Scheduled for standard of care biopsy or MRI; * Fluent in language of consent (English, Spanish, or French); * Ability to give informed consent; * Able to provide a breath sample.

Exclusion criteria

* Prior history of breast cancer; * Previous surgical biopsy or surgical excision of breast cancer in the past six months; * History of cancer (except basal cell or squamous cell carcinoma of the skin) in the past year; * Acute respiratory infection and/or symptoms in the past seven days; * MRI BI-RADS 3 undergoing active surveillance (MRI requiring six-month follow-up). * Pregnant or become pregnant during the study.

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome 1	36 months	Classification performance metrics characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) derived from spectral features of exhaled alveolar breath obtained using Breathe BioMedical's cavity ring-down spectrometer in women aged 40-74.

Secondary

Measure	Time frame	Description
Secondary Outcome 1	36 months	Discriminative features between women with breast cancer and women without breast cancer.
Secondary Outcome 2	36 months	Features associated with breast cancer between participants with dense breast tissue and those with non-dense breast tissue.
Secondary Outcome 3	36 months	Classification performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.
Secondary Outcome 4	36 months	Variability in features before and after definitive management of breast cancer, including surgical resection.
Secondary Outcome 5	36 months	Pooled and analyzed de-identified data from this, previous, and future breath analysis studies to continue to develop Breathe BioMedical's technology and machine learning algorithms.

Countries

Canada, United States

Contacts

CONTACTSandra Veenstra

sandra.veenstra@breathebiomedical.com(506) 855-2400

Outcome results