Identifying breath patterns in women with breast cancer
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients to Detect Breast Cancer
This study is trying to see if the breath patterns of women with breast cancer are different from those without the disease to help improve breast cancer detection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5175 (estimated) |
| Ages | 40 Years to 74 Years |
| Sex | Female |
| Sponsor | Breathe BioMedical Inc Industry-sponsored |
| Locations | 4 sites (Washington D.C., District of Columbia and 3 other locations) |
| Trial ID | NCT06512350 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the breath profiles of women diagnosed with breast cancer to those without the disease, focusing on identifying specific patterns that could aid in breast cancer detection. Participants will be women aged 40 to 74 with mammogram-confirmed dense breast tissue who are scheduled for standard breast cancer screening procedures. They will provide a breath sample and complete a medical history questionnaire, with samples collected prior to their biopsy or MRI. The study utilizes advanced infrared spectroscopy and machine learning algorithms to analyze the breath samples for potential disease-specific markers.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 74 with mammography-confirmed dense breast tissue who are scheduled for a biopsy or MRI.
Not a fit: Patients with fatty breast tissue or a prior history of breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive method for early detection of breast cancer in women with dense breast tissue.
How similar studies have performed: While the approach of using breath analysis for cancer detection is innovative, similar studies have shown promise in other cancers, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia and 3 other locations
- GW Comprehensive Breast Center — Washington D.C., District of Columbia, United States (Recruiting)
- Mayo Clinic Breast Clinic — Jacksonville, Florida, United States (Recruiting)
- Duke University Medical Cente — Durham, North Carolina, United States (Recruiting)
- Weinstein Imaging Associates — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Sandra Veenstra
- Email: sandra.veenstra@breathebiomedical.com
- Phone: (506) 855-2400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.