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

Breast Cancer Clinical Trial

Official title:

Identification and Differentiation of Breast Masses by Vibro-Acoustography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627614
• Other study ID #: 284-06
• Secondary ID: P30CA015083CDR00
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: June 1, 2015
• Start date: March 2006
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Alizad A, Whaley DH, Greenleaf JF, Fatemi M. Image features in medical vibro-acoustography: in vitro and in vivo results. Ultrasonics. 2008 Nov;48(6-7):559-62. doi: 10.1016/j.ultras.2008.04.014. Epub 2008 May 25. — View Citation

Alizad A, Whaley DH, Urban MW, Carter RE, Kinnick RR, Greenleaf JF, Fatemi M. Breast vibro-acoustography: initial results show promise. Breast Cancer Res. 2012 Sep 29;14(5):R128. doi: 10.1186/bcr3323. — View Citation

Chen S, Aquino W, Alizad A, Urban MW, Kinnick R, Greenleaf JF, Fatemi M. Thermal safety of vibro-acoustography using a confocal transducer. Ultrasound Med Biol. 2010 Feb;36(2):343-9. doi: 10.1016/j.ultrasmedbio.2009.10.003. — View Citation

Kamimura HA, Urban MW, Carneiro AA, Fatemi M, Alizad A. Vibro-acoustography beam formation with reconfigurable arrays. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Jul;59(7):1421-31. doi: 10.1109/TUFFC.2012.2343. — View Citation

Urban MW, Alizad A, Aquino W, Greenleaf JF, Fatemi M. A Review of Vibro-acoustography and its Applications in Medicine. Curr Med Imaging Rev. 2011 Nov 1;7(4):350-359. — View Citation

Urban MW, Chalek C, Haider B, Thomenius KE, Fatemi M, Alizad A. A beamforming study for implementation of vibro-acoustography with a 1.75-D array transducer. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Mar;60(3):535-51. doi: 10.1109/TUFFC.2013.2595 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection and differentiation of breast masses with an estimated specificity of = 70% using vibro-acoustography (VA) imaging		25 minutes for Breast VA imaging	No