A Pilot Study To Evaluate the Effectiveness of Pulsed Time-Domain Optical Spectroscopy for Monitoring the Responses in Neoadjuvant Treatments of Locally-Advanced Breast Cancer

Participation Requirements

• Sex:

  FEMALE

• Eligible Ages:

  20 to 80

Participation Criteria

Inclusion Criteria:

* Locally Advance Breast Cancer
* 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 women of between 20 and 80 years of age, inclusive, on the day the Informed Consent Form is signed;
* Subjects must be women who will be receiving neoadjuvant radiation therapy and/or chemotherapy for locally-advanced breast cancer.
* Subjects of childbearing potential must be using an acceptable method of birth control. Subjects not of childbearing potential are defined as either surgically sterile or post-menopausal. Post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the Informed Consent Form

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 purified water, soybean oil, sucrose, polysorbate 80, oleic acid, EDTA, benzalkonium chloride, FD\&C caramel color, butylated hydroxyanisole, and/or sodium hydroxide;
* 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.