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

Primary Purpose

Breast Cancer, Breast Abnormalities

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Imaging with Contrast
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound Imaging

Arm Description

Ultrasound Imaging with Contrast

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 23, 2008
Last Updated
October 16, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00722683
Brief Title
Evaluate Breast Masses Using a New Method of Ultrasound Contrast to Detect Abnormal Blood Flow in Breasts
Official Title
Characterization of Breast Masses Using a New Method of Ultrasound Contrast Agent Imaging in 3D Mapping of Vascular Anomalies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Study Start Date
April 2001 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Abnormalities

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Imaging
Arm Type
Experimental
Arm Description
Ultrasound Imaging with Contrast
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Imaging with Contrast
Intervention Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry L. LeCarpentier, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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