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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: GE Healthcare

Criteria

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