Intraoperative Imaging of Breast Cancer With Indocyanine Green
Intraoperative Imaging of Breast Cancer With Indocyanine Green
According to the World Health Organization, breast cancer is the most common cancer in women,
 and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000
 women perished from the disease in 2002. Surgery remains the best option for patients
 presenting with operable Stage I, II or III cancers. Breast conservation surgery has been
 shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast
 cancer are breast conservation candidates. However, the need to achieve negative tumor
 margins often requires a second operation (re-excision) in up to 70% of the women having
 lumpectomy surgery. Currently, tumor margins assessment in the operating room is often
 assessed grossly by palpation. The ability to evaluate tumor margin using our proposed
 intraoperative imaging technique may provide the surgeon with an alternative, and hopefully,
 more sensitive method to assess tumor margins which may decrease re-excision and the
 morbidity associated with additional surgery, and, perhaps, lower the risk of local regional
 recurrence.
Inclusion Criteria:

 1. Adult patients over 18 years of age

 2. Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular
 carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates
 (i.e. lumpectomy +/- sentinel node biopsy).

 3. Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by
 palpation or by breast imaging findings including mammogram, US and/or breast MRI.
 Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are
 deemed breast conservation candidates.

 4. Subject capable of giving informed consent and participating in the process of
 consent.

 Exclusion Criteria:

 1. Newly diagnosed breast cancer patients who are not breast conservation candidates and
 those with multicentric breast cancer (breast cancer documented in multiple quadrants
 by breast imaging or exam)

 2. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin
 (hCG) within 72 hours of surgery

 3. Subjects with a history of iodide allergies

 4. At-risk patient populations

 1. Homeless patients

 2. Patients with drug or alcohol dependence

 3. Patients unable to participate in the consent process