Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™). Ultrasound images and videos of tumor and lymph nodes in underarm area taken. Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery. Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.

Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™) before breast ultrasound.

Perflutren Protein-Type A Microspheres Injectable Suspension

Ultrasound images of breast and videos of tumor and lymph nodes in underarm area taken after Perflutren Protein-Type A Microspheres Injectable Suspension injection.

Contrast-Enhanced Ultrasound (CEUS)

Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery.

Biopsy + Radioactive Seed Placement

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

Phone Call

Basak Dogan, MD

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.

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.

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

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

Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.

GE Healthcare

M.D. Anderson Cancer Center

Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.

CEUS Sentinel Lymph Node Imaging + Guided Biopsy

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Basak Dogan/Diagnostic Radiology

Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique

Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node (SNL) biopsy and radioactive seed placement.

CEUS SNL Imaging + Guided Biopsy

Overall Study

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram.

Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

Needle localized breast biopsy with specimen x-ray

Low dose radioactive seed followed by surgery and mammogram

Charles E. Cox, MD, FACS

RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions that cannot be felt upon examination.

OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods in these patients. III. Demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients. IV. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two diagnostic arms. Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram. Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

Comparison of Two Types of Biopsy in Patients With Breast Lesions

Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy

Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on tissue loss in patients with nonpalpable breast lesions.

Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time in patients with nonpalpable breast lesions.

Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients	NCT02321527	Breast Cancer	Perflutren Prot... Contrast-Enhanc... Biopsy + Radioa... Phone Call	18 Years -	M.D. Anderson Cancer Center
Comparison of Two Types of Biopsy in Patients With Breast Lesions	NCT00006031	Breast Cancer	Needle localize... Low dose radioa...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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