NCT00627614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

8.1 years

First QC Date

February 29, 2008

Last Update Submit

June 1, 2015

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging

    25 minutes for Breast VA imaging

Study Arms (1)

breast imaging study

EXPERIMENTAL
Other: breast imaging study

Interventions

breast imaging studyOTHER

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.

breast imaging study

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Related Publications (6)

  • 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.

    PMID: 23021305RESULT

  • 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.

    PMID: 23475919RESULT

  • 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.

    PMID: 22828838RESULT

  • 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. doi: 10.2174/157340511798038648.

    PMID: 22423235RESULT

  • 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.

    PMID: 20113864RESULT

  • 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.

    PMID: 18599102RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Azra Alizad, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 3, 2008

Study Start

March 1, 2006

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

US(1)