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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.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00722683
First received: July 23, 2008
Last updated: October 17, 2011
Last verified: September 2011
History of Changes
  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 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:

U.S. FDA Resources

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.

  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

No publications provided

Responsible Party: Jerry L. LeCarpentier, Ph.D., University of Michigan Health System
ClinicalTrials.gov Identifier: NCT00722683     History of Changes
Other Study ID Numbers: 2001-0184
Study First Received: July 23, 2008
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013