NCT00722683

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

9.3 years

First QC Date

July 23, 2008

Last Update Submit

October 16, 2017

Conditions

Breast CancerBreast Abnormalities

Study Arms (1)

Ultrasound Imaging

EXPERIMENTAL

Ultrasound Imaging with Contrast

Procedure: Ultrasound Imaging with Contrast

Interventions

Ultrasound Imaging with ContrastPROCEDURE

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.

Ultrasound Imaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects who have breast masses and scheduled for core biopsy.

You may not qualify if:

  • Pregnant or lactating females.
  • Females who have heart problems or sensitivity to contrast agents.
  • Females who have had previous surgery for breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock WavesContrast Media

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaDiagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Jerry L. LeCarpentier, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

April 1, 2001

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)