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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This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722683
First Posted: July 25, 2008
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jerry LeCarpentier PhD, University of Michigan
  Purpose
The purpose of this study is to determine if breast imaging with ultrasound can be improved by using 1) a ultrasound attachment with two transducers and 2) a contrast agent. These changes might allow smaller blood vessels to be seen than under the way breast ultrasound is usually performed.

Condition Intervention
Breast Cancer Breast Abnormalities Procedure: Ultrasound Imaging with Contrast

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Jerry LeCarpentier PhD, University of Michigan:

Enrollment: 0
Study Start Date: April 2001
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound Imaging
Ultrasound Imaging with Contrast
Procedure: Ultrasound Imaging with Contrast

An ultrasound contrast agent, Definity, will be administered started through the IV line already in use. The imaging will be performed to map vascular flow.

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.


Detailed Description:

The purpose of this study is to determine if performing ultrasound with an attachment made up of two transducers (rather than just a single transducer) will provide more information about the blood vessels in the breast than the current attachment.

The study will also examine the question of whether use of an ultrasound contrast agent will the scanner to see smaller blood vessels than are detected without the agent.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  More Information

Responsible Party: Jerry LeCarpentier PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00722683     History of Changes
Other Study ID Numbers: 2001-0184
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No