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Evaluate Breast Masses Using a New Method of Ultrasound Contrast to Detect Abnormal Blood Flow in Breasts

This study has been completed.
Information provided by:
University of Michigan Identifier:
First received: July 23, 2008
Last updated: October 17, 2011
Last verified: September 2011
The purpose of this study is to determine if performing ultrasound with an attachment made up of two transducers will give us more information about the blood vessels in the breast than the current attachment that has only one transducer and to decide if using an ultrasound agent which enhances the ultrasound signal will help see smaller blood vessels than can be seen without the agent.

Condition Intervention
Breast Cancer
Breast Abnormalities
Procedure: Ultrasound Imaging with Contrast to Map Vascular Flow

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Characterization of Breast Masses Using a New Method of Ultrasound Contrast Agent Imaging in 3D Mapping of Vascular Anomalies

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Estimated Enrollment: 50
Study Start Date: April 2001
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Procedure: Ultrasound Imaging with Contrast to Map Vascular Flow
An ultrasound contrast agent, Definity, will be started through the IV line already in place. The breast will be scanned by a double ultrasound transducer system in a holder over the area of the breast to be biopsied. The machine will be set with different settings and the scan repeated, possibly multiple times.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female subjects who have breast masses and scheduled for core biopsy.

Exclusion Criteria:

  • Pregnant or lactating females.
  • Females who have heart problems or sensitivity to contrast agents.
  • Females who have had previous surgery for breast cancer.
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Please refer to this study by its identifier: NCT00722683

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Jerry L. LeCarpentier, Ph.D. University of Michigan
  More Information

Responsible Party: Jerry L. LeCarpentier, Ph.D., University of Michigan Health System Identifier: NCT00722683     History of Changes
Other Study ID Numbers: 2001-0184
Study First Received: July 23, 2008
Last Updated: October 17, 2011 processed this record on April 26, 2017