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

NCT ID: NCT00722683

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Breast Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound Imaging

Ultrasound Imaging with Contrast

Group Type EXPERIMENTAL

Ultrasound Imaging with Contrast

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jerry LeCarpentier PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry L. LeCarpentier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2001-0184

Identifier Type: -

Identifier Source: org_study_id