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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Azra Alizad, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00627614
First received: February 29, 2008
Last updated: June 1, 2015
Last verified: June 2015

February 29, 2008
June 1, 2015
March 2006
April 2014   (final data collection date for primary outcome measure)
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 ]
Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00627614 on ClinicalTrials.gov Archive Site
Not Provided
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Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer
Identification and Differentiation of Breast Masses by Vibro-Acoustography

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
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.

Experimental: breast imaging study
Intervention: Other: breast imaging study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00627614
284-06, P30CA015083, CDR0000583016
Yes
Not Provided
Not Provided
Azra Alizad, Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Azra Alizad, MD Mayo Clinic
Mayo Clinic
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP