NCT06512350 · Breathe BioMedical Inc
Identifying Patterns in the Breath of Individuals With Breast Cancer
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Durham, North Carolina
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations