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
This study will investigate optical tissue characteristics as a function of neoadjuvant breast cancer treatment. Our objective in this pilot study will be to identify diffuse optical spectroscopy parameters that change with treatment and that may correlate with pathological response. The ultimate goal is to use such parameters ultrasound as an early predictor of pathological partial or complete response in women with locally advanced breast cancer receiving treatment with neoadjuvant treatments such as chemotherapy or neoadjuvant combined modality chemotherapy and radiotherapy.
• 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