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NCT Number: NCT06512350

Identifying Patterns in the Breath of Individuals With Breast Cancer

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.

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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

GW Comprehensive Breast Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary Outcome 1

    Time frame: 24 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 outcomes

  1. Secondary Outcome 1

    Time frame: 24 months

    Discriminative features between women with breast cancer and women without breast cancer.

  2. Secondary Outcome 2

    Time frame: 24 months

    Features associated with breast cancer between participants with dense breast tissue and those with non-dense breast tissue.

  3. Secondary Outcome 3

    Time frame: 24 months

    Classification performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.

  4. Secondary Outcome 4

    Time frame: 24 months

    Variability in features before and after definitive management of breast cancer, including surgical resection.

  5. Secondary Outcome 5

    Time frame: 24 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Veenstra

CONTACT

[email protected]

(506) 855-2400 ext. 234

Sponsors and collaborators

Lead sponsor

Breathe BioMedical Inc

Industry

Collaborators

  • Duke University
  • George Washington University
  • Mayo Clinic
  • Weinstein Imaging Associates

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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