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.