Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

There is considerable interest in developing imaging protocols to monitor and predict breast
cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before
surgical removal of the tumor, both prior to and as early as possible during the course of
treatment. The efficacy and practicality of conventional imaging approaches in the NAC
setting varies and identifies the need for alternate functional imaging strategies. Diffuse
optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients
to be followed before and during treatment with a cost-effective, bedside, handheld scanning
probe. DOSI is a non-invasive technology developed at the University of California, Irvine
Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately
200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant
chemotherapy (NAC).

As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic
complete response (pCR), which is defined as no tumor cell left in the resected tissue at
surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly
with no risk/discomfort, this experimental imaging modality could be used as an indicator of
pathologic response which has been an established indicator of long-term survival. The
investigators long-term goal is to provide oncologists with a relatively simple, risk-free
bedside tool that can be used to help inform medical decisions on chemotherapy regimen,
duration, and timing of surgery, thereby maximizing therapeutic response and minimizing
unnecessary toxicity.

Inclusion Criteria:

- Females between the ages of 21 and 80. Specific to Study part #1

- Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast
abnormality greater than 1cm in size Specific to Study part #2

- Enrolled in study part #1

- Diagnosed with histologically-proven invasive breast cancer

- Prescribed neoadjuvant chemotherapy for breast cancer

Exclusion Criteria:

- Pregnant

- Unable to give written, informed consent.