Multi-scale Modeling of Breast Conserving Therapy

This is a single-center, prospective, pilot observation study. Eligible subjects who enroll
in this study will begin at the time of informed consent, which will occur during the
pre-operative, surgical evaluation time. Once consented, a 3-dimensional 180° camera surface
image will be taken and a pain-scale score will be completed. Data from the medical history
will be recorded. As standard of care, the surgery will be scheduled and performed. Following
surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that
will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3.
The pain scale score will be administered pre and post ultrasound on the 5 post-operative
visits. A judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons.
The participant's role in the study will be completed after the week 24 visit.

Inclusion Criteria:

1. Adult females ≥ age 30 years

2. Have early stage (Stage I, II), non-metastatic breast cancer

3. Planned to receive BCT

4. Have received a pre-operative mammogram within 30 days of surgery

5. Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery

6. Planned to receive post-surgery radiotherapy by whole breast radiotherapy

7. Signed informed consent form prior to any research assessment

Exclusion Criteria:

1. Adult females younger than 30 years of age

2. Previous breast cancer

3. Neo-adjuvant therapy for breast cancer

4. Pregnant or nursing females

5. Participation in a study of investigational drug in the previous 30 days or 5
half-lives of the investigational drug