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

Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

Men and women with either a biopsy confirmed diagnosis of breast cancer and receiving neoadjuvant chemotherapy.

Cohort 2 - Breast Mass Characterization:

Men and women suspected of having a mammary, benign or malignant mass and are schedule to undergo diagnostic and clinical work-up.

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.