Evaluate Breast Masses Using a New Method of Ultrasound C... | NCT00722683

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

NCT00722683

Sponsor

University of Michigan

Status

Withdrawn

Last Update Posted

Oct 18, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Cancer
Breast Abnormalities

Interventions

Ultrasound Imaging with Contrast

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Aug 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound Imaging	Experimental	Ultrasound Imaging with Contrast	Procedure: Ultrasound Imaging with Contrast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Imaging with Contrast	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.

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jerry L. LeCarpentier, Ph.D.	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Health System		Ann Arbor	Michigan	48109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves
D003287	Contrast Media

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided