Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)
Condition: Breast Cancer
MeSH terms: Fibrocystic Breast Disease
Study type: Observational

Summary: 
      The overarching goal of the proposed research is to evaluate whether qualitative and
      quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing
      suspicious indeterminate cystic appearing breast masses and ultimately determine whether or
      not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses
      (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by
      ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic
      lesions can be followed and do not need biopsy intervention.
    

Detailed description: 
      Breast cancer is the most frequently diagnosed cancer in women. To diagnose these cancers,
      more than 1.6 million breast biopsies are performed each year in the United States, of which
      more than 60% have benign pathology. A large percentage of the benign biopsies show
      fibrocystic changes of the breast on histology. These biopsies can be avoided with better
      diagnostic tools identifying fibrocystic change. The Investigators propose that contrast
      enhanced ultrasound (CEUS) can aid in classifying and predicting if a cystic appearing breast
      mass is benign or malignant, and can be a supplemental imaging tool to mammography and
      conventional gray-scale ultrasound (US).

      In standard clinical practice, if a breast mass appears to be cystic on gray-scale US but has
      some suspicious features which make it difficult to tell if the mass is truly cystic or
      solid, the decision making for follow-up versus biopsy is difficult. This leads to
      unnecessary biopsies (false positives) since many of these masses are a sequel of benign
      fibrosis and fibrocystic changes of the breast. CEUS may help classify these masses as cystic
      or solid. The central premise is based on the microbubble contrast agent used in CEUS, since
      it stays within the blood pool and will only show enhancement if a mass has solid components
      and has vascular flow.

      The Investigators hypothesize that indeterminate cystic breast masses will not enhance on
      CEUS and will correlate with benign pathology. Quantitative CEUS parameters will also help
      classify these lesions. If this is the case, then in the future, the non-enhancing cystic
      breast masses will not need to be biopsied. This will decrease patient anxiety, unnecessary
      interventions, and save resources.

      The investigators will investigate qualitative and quantitative parameters on CEUS in
      evaluating indeterminate cystic breast masses given BIRADS 4 and correlate these with
      histopathology obtained by biopsy and/or surgery. This data will help them to develop
      protocols to better distinguish between benign and malignant cystic appearing breast masses.
    

Intervention name(s): Definity
Intervention type(s): Drug
Intervention description(s): The contrast agent, Definity, 10 µL/kg, will be administered through an intravenous catheter placed in an antecubital vein. Definity is an FDA approved contrast agent for cardiac studies and will be an off-label use in this study. The agent will be injected as a single intravenous bolus followed by a 10 mL saline flush (0.9% NaCl). Images will be recorded with clip function for 90 seconds following the administration of contrast while the probe is stabilized and minimal pressure applied. During this time, qualitative evaluation of tumor enhancement will be observed, and the presence of contrast uptake within the tumor will be categorized.
Other intervention name(s): Perflutren
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will be performed as a prospective study at LAC+USC in the mammography
        department. Our project will enroll approximately 135 women > 18 years of age with breast
        masses evaluated by conventional US given BIRADS 4 and recommended for ultrasound guided
        biopsy.