Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers

PRIMARY OBJECTIVES:

I. To define the feasibility of the current photoacoustic imaging (PAI) technology in various
groups of human subjects.

SECONDARY OBJECTIVES:

I. To define the utility of the current PAI on various groups of human subjects.

II. When possible, via means of an existing data review, PAI will be correlated with standard
imaging modalities performed on patients as routine part of clinical care or on protocol.

III. When possible, via means of an existing data review, PAI will be compared to pathologic
specimens.

IV. When possible, via means of an existing data review, PAI data will be correlated with
outcomes of patients to therapies they receive.

OUTLINE:

Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging
sessions for 6 months.

Inclusion Criteria:

- ALL GROUPS:

- No restriction on race or ethnic background.

- Subject or legal representative must understand the investigational nature of the
study and sign an independent Ethics Committee/Institutional Review Board approved
written informed consent prior to receiving any study related procedure.

- HEALTHY VOLUNTEERS:

- No history of antimicrobial therapy or drug treatment including anti-hypertensive,
diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period.

- No history of diabetes.

- No history of cancer to the body site to be imaged.

- BREAST, SARCOMA, SKIN CANCER, AND SUPERFICIAL MALIGNANCY PATIENTS:

- Biopsy-proven aforementioned malignancy.

- SURGICAL FLAP PATIENTS:

- Need for plastic surgery reconstruction with a free or rotational flap.

Exclusion Criteria:

- Uncontrolled illness including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study
requirements.

- Unwilling or unable to follow protocol requirements or provide consent.

- Any condition which in the Investigator?s opinion deems the subject an unsuitable
candidate to undergo imaging procedure.