Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients

Study Procedures:

If you agree and are eligible to take part, you will receive perflutren protein type A by
injection under the skin near the nipple. After you receive the injection, the radiologist
will take more ultrasound images and videos of the tumor and lymph nodes in the underarm
area.

You will have a biopsy of the sentinel lymph node that was identified in the ultrasound and
a titanium clip marker will be inserted into the node. The clip helps distinguish the
biopsied node from other nodes. You will be told the results of biopsy. After the biopsy, a
radioactive seed may be inserted into the node to allow the surgeon to find and remove it
during your surgery, an extra node may be removed at that time.

You will still have standard of care sentinel lymph node biopsy during your already
scheduled surgery. You will sign a separate surgical consent form that explains this
procedure and its risks.

You will be called by phone 30 days after the seed is removed to check for any side effects.
This phone call should take about 10 minutes.

Length of Study:

Your active participation in this study will be over the follow up phone call.

This is an investigational study. Perflutren protein type A is FDA approved and commercially
available for use in contrast-enhanced echocardiograms. Its use in this study is
investigational.

Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. 18 years or older.

2. Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by
Ultrasound or Mammography.

3. No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign
subsequent FNA biopsy.

Exclusion Criteria:

1. Pregnant or nursing women

2. Prior SLN dissection

3. Neoadjuvant chemotherapy.

4. Prior axillary lymph node surgery.

5. Prior history of ipsilateral breast cancer.

6. Known or suspected: Cardiac shunts

7. Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin

8. Known or suspected: hypersensitivity to a prior OPTISON administration