A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy

This research study is a Pilot Study, which is the first time investigators are examining
this study device for this indication.

The FDA (the U.S. Food and Drug Administration) has not approved DBT-TOBI as a diagnostic
scan for this disease.

The DBT-TOBI scan system is designed to deliver low power laser lights through a person's
body tissue and collect data about the light that is transmitted through. In this study, the
DBT-TOBI will be used to scan the breast. The data that can be collected through the scan is
the total hemoglobin concentration and hemoglobin oxygen saturation. Hemoglobin is the
protein found in red blood cells that is responsible for carrying oxygen to the various
tissues in the body. These two data types are thought to provide insight into the response of
the breast cancer to neoadjuvant chemotherapy treatment response. The researchers are looking
to find if these scans will help show changes in the hemoglobin levels, thus showing how the
cancer is reacting to treatment. The study is focused on 2 types of breast cancer called
triple negative breast cancer and Human Epidermal Growth Factor Receptor 2 (HER2).

Inclusion Criteria:

- Female

- Participant will be receiving neoadjuvant chemotherapy at the Massachusetts General
Hospital (MGH) Center for Breast Cancer.

- Participants must have measurable disease, defined as at least one lesion that can be
accurately measured as ≥10 mm in the longest diameter with breast MRI, mammography or
ultrasound. See Section 11 for the evaluation of measurable disease.

- Patients must have Humane Epidermal Growth Factor Receptor (HER2) positive (regardless
of Hormone Receptor (HR) status) or Triple Negative (TN) disease as confirmed by
pathology. HER2 positive is defined according to ASCO-CAP guidelines, and patient will
be receiving HER2 directed therapy. TN is defined as Estrogen Receptor <=1%,
Progesterone Receptor <= 1%, and HER2 negative by American Society of Clinical
Oncology (ASCO) - College of American Pathologists (CAP) guidelines. For tumors with
discordant or borderline receptor findings, the Principal Investigator will adjudicate
the final decision.

- Age 18 and above.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with open wounds on the breast.

- Patients who have undergone breast surgery or breast biopsy 10 days or less prior to
the first planned optical imaging scan.

- Patients with breast implants.

- Patients whose primary lesion is outside the field of view of the optical imaging
system.

- A history of ipsilateral disease (including invasive breast cancer, ductal carcinoma
in situ (DCIS), and benign lesions) or breast surgery.

- Patients who are pregnant or trying to become pregnant.

- Medical or psychiatric conditions which, in the opinion of the investigator, might
result in risk to the subject from participation in the study or inability to complete
the study.

- For patients who agree to participate in the optional MRI study, these following
additional exclusion criteria also apply:

- Neurostimulators;

- Pacemakers;

- Implanted metallic material or devices (metal implants or large tattoos in the
field of view);

- Severe claustrophobia;

- Physical characteristics (weight and/or size) that exceed the capabilities of the
MRI scanner;

- Known allergy or hypersensitivity reactions to gadolinium, versetamide, or any of
the inert ingredients in gadolinium-based contrast agents;

- Severe renal insufficiency, e.g., estimated glomerular filtration rate < 30
mL/min.