Breast Cancer Clinical Trial
Official title:
Qualitative and Quantitative Analysis of Cystic Breast Masses by Contrast Enhanced Ultrasound: Is Biopsy Necessary?
NCT number | NCT02887937 |
Other study ID # | HS-16-00483 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 16, 2016 |
Est. completion date | April 29, 2018 |
Verified date | May 2018 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | April 29, 2018 |
Est. primary completion date | April 29, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | USC Department of Radiology | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Wright Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lesions of malignant vs. benign biopsy histology | The proportion of breast masses with presence of contrast uptake on CEUS will be calculated for lesions of malignant vs. benign biopsy histology, grouped by BIRADS categories | 0-2 months | |
Secondary | classification rule with the CEUS parameters | We will build a classification rule with the CEUS parameters and then assess whether this rule can classify benign or malignant BIRADS 4a cystic lesions correctly. | 11-12 months |
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