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Withdrawn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
About this trial
This is an interventional diagnostic trial for Breast Cancer
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.
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
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Withdrawn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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