Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer

This study is currently recruiting participants.
Verified January 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00627614
First received: February 29, 2008
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer.

PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.


Condition Intervention
Breast Cancer
Other: breast imaging study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Identification and Differentiation of Breast Masses by Vibro-Acoustography

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging [ Time Frame: 5 to 10 minutes for Breast VA imaging ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: breast imaging study

    1. A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging.

    2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure.

Detailed Description:

OBJECTIVES:

  • To study in vivo detection of breast masses by vibro-acoustography (VA) imaging.
  • To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.

OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Known breast mass identified as BI-RADS 4 or 5

    • Patients with proven breast cancer who are undergoing chemotherapy before surgery are eligible
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627614

Locations
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Azra Alizad, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Azra Alizad, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00627614     History of Changes
Other Study ID Numbers: 284-06, P30CA015083, CDR0000583016
Study First Received: February 29, 2008
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014