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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00627614
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Other: breast imaging study

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification and Differentiation of Breast Masses by Vibro-Acoustography
Study Start Date : March 2006
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: breast imaging study 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.



Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627614


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

Publications:
Responsible Party: Azra Alizad, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00627614     History of Changes
Other Study ID Numbers: 284-06
P30CA015083 ( U.S. NIH Grant/Contract )
CDR0000583016 ( Other Identifier: NCI )
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Azra Alizad, 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