Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy

Cohort 1 - Neoadjuvant Chemotherapy Monitoring: Inclusion Criteria: * Subjects must give appropriate written informed consent prior to participation in the study; * Subjects must be able and willing to comply with the safety procedures during the Scanning Period; * Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed; * Subjects must be receiving neoadjuvant chemotherapy for locally-advanced breast cancer. * Biopsy-confirmed diagnosis of locally advanced breast cancer; of all molecular subtypes (ER+/-, PR+/-, HER2+/-). Exclusion Criteria: * Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue; * Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast; * Subjects with a current or past medical history of connective tissue disease; * Subjects who are pregnant or lactating; * Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator; * Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations; * Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period; * Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and * Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study. Cohort 2 - Breast Mass Characterization: Inclusion Criteria: * Subjects must give appropriate written informed consent prior to participation in the study; * Subjects must be able and willing to comply with the safety procedures during the Scanning Period; * Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed; * Subjects must be referred to breast diagnostic clinic for investigation of a breast mass. Exclusion Criteria: * Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue; * Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast; * Subjects with a current or past medical history of connective tissue disease; * Subjects who are pregnant or lactating; * Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator; * Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations; * Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period; * Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and * Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.