Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/17/2018 |
| Start Date: | August 16, 2016 |
| End Date: | April 29, 2018 |
Qualitative and Quantitative Analysis of Cystic Breast Masses by Contrast Enhanced Ultrasound: Is Biopsy Necessary?
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.
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.
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.
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.
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.
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