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

June 19, 2012 updated by: Mayo Clinic

In Vivo Breast Imaging by Vibro-acoustography

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients with and without breast masses

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
diseased

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mostafa Fatemi, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 729-01-0
  • P30CA015083 (U.S. NIH Grant/Contract)
  • CDR0000583249 (Registry Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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