RecruitingNCT06512350

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

Sponsor: Breathe BioMedical Inc

Trial Details

ConditionBreast Cancer
StatusRecruiting
Participants5,175
Est. Completion1 Dec 2027
Last Updated22 Apr 2026

Primary Outcome

Primary Outcome 1

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

United States
View Registry Entry

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