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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Azra Alizad, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00627614
First received: February 29, 2008
Last updated: August 12, 2014
Last verified: August 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: 25 minutes for Breast VA imaging ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: March 2006
Study Completion Date: April 2014
Primary Completion Date: April 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:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Suspiciuos breast lesions identified as BI-RADS 4 or 5 and 3
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627614

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Azra Alizad, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Azra Alizad, PI, 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: August 12, 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 October 01, 2014