Vibro-Acoustography Imaging in Finding Breast Microcalcif... | NCT00626119

Studies
Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women

NCT00626119

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jun 21, 2012Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

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

ID	Type	Description	Link
P30CA015083	U.S. NIH Grant/Contract		View source
CDR0000583249	Registry Identifier	NCI

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Feb 28, 2008

First Submission Date that Met QC Criteria

Feb 28, 2008

First Posted Date

Feb 29, 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

Jun 19, 2012

Last Update Posted Date

Jun 21, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

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

RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of finding microcalcifications and lesions in the breast.

PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in finding breast microcalcifications and lesions in women.

Detailed Description

OBJECTIVES:

To further develop a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging.
To demonstrate and evaluate the capability of VA imaging in detecting microcalcifications and lesions inside the human breast.

OUTLINE: Participants undergo vibro-acoustography (VA) imaging of the breast using ultrasonography over 90 minutes. Participants may also undergo further imaging using clinical ultrasonography.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Further development of a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging		one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Meets one of the following criteria:
- Healthy participant
- Proven microcalcifications and/or lesions in the breast
Hormone status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
Not pregnant or nursing
No condition that does not allow proper use of study imaging devices

PRIOR CONCURRENT THERAPY:

Not specified

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

patients with and without breast masses

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mostafa Fatemi, PhD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Cancer Center		Rochester	Minnesota	55905	United States

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

Label	Type	Description	Intervention Names
Control
diseased