Clinical trial NCT02887937: Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)
Official title: Qualitative and Quantitative Analysis of Cystic Breast Masses by Contrast Enhanced Ultrasound: Is Biopsy Necessary?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Wright Foundation
First posted: 2016-09-02
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* recommended for an ultrasound guided biopsy due to breast mass detection

Exclusion Criteria:

* \< 18 years of age
* prior history of breast cancer
* prior history of biopsy for that specific lesion
* any condition that would be a contraindication to the microbubble contrast agent used in CEUS such as pulmonary hypertension, 3cardiac shunts, and allergy to perflutren.

Primary outcomes:
measure: lesions of malignant vs. benign biopsy histology
timeFrame: 0-2 months
Secondary outcomes:
measure: classification rule with the CEUS parameters
timeFrame: 11-12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Department of Radiology
state: California
Study officials:
affiliation: University of Southern California
name: Sandy C Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: