Clinical Trial: Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Qualitative and Quantitative Analysis of Cystic Breast Masses by Contrast Enhanced Ultrasound: Is Biopsy Necessary?

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 Summary:

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 CE
Sponsor: University of Southern California

Current Primary Outcome: lesions of malignant vs. benign biopsy histology [ Time Frame: 0-2 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: classification rule with the CEUS parameters [ Time Frame: 11-12 months ]

Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: August 29, 2016
Date Started: September 2016
Date Completion: August 2017
Last Updated: September 6, 2016
Last Verified: September 2016