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Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)

NCT02887937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2018-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Definity

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.

Sponsors & Collaborators

  • Wright Foundation

    collaborator UNKNOWN

  • University of Southern California

    lead OTHER

Principal Investigators

  • Sandy C Lee, MD · University of Southern California

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-16
Primary Completion
2018-04-29
Completion
2018-04-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887937 on ClinicalTrials.gov