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

Breast Cancer Clinical Trial

Official title:

Characterization of Breast Masses Using a New Method of Ultrasound Contrast Agent Imaging in 3D Mapping of Vascular Anomalies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00722683
• Other study ID #: 2001-0184
• Status: Withdrawn
• Phase: N/A
• First received: July 23, 2008
• Last updated: October 16, 2017
• Start date: April 2001
• Est. completion date: December 2010

Study information

• Verified date: October 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Abnormalities
• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States,