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Evaluate Breast Masses Using a New Method of Ultrasound Contrast to Detect Abnormal Blood Flow in Breasts.
This study is ongoing, but not recruiting participants.
Sponsored by: University of Michigan
Information provided by: University of Michigan
ClinicalTrials.gov Identifier: NCT00722683
  Purpose

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. 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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ultrasound
Drug Information available for: Octafluoropropane
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Characterization of Breast Masses Using a New Method of Ultrasound Contrast Agent Imaging in 3D Mapping of Vascular Anomalies

Further study details as provided by University of Michigan:

Estimated Enrollment: 50
Arms Assigned Interventions
A: Experimental 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722683

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

Responsible Party: University of Michigan Health System ( Jerry L. LeCarpentier, Ph.D. )
Study ID Numbers: 2001-0184
Study First Received: July 23, 2008
Last Updated: July 24, 2008
ClinicalTrials.gov Identifier: NCT00722683  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Skin Diseases
Vascular Malformations
Breast Neoplasms
Congenital Abnormalities
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009