Clinical trial NCT02321527: Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
Official title: Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Ultrasound Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Microbubble contrast-enhanced ultrasound
CEUS
Sentinel lymph nodes
SLN
Perflutren Protein-Type A Microspheres Injectable Suspension
OPTISON™
Ultrasound
Breast biopsy
Radioactive seed
Phone call
Fine needle aspiration
FNA
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2014-12-22
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Basak Dogan, MD
role: PRINCIPAL_INVESTIGATOR
References: