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

NCT ID: NCT00627614

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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breast imaging study

Group Type EXPERIMENTAL

breast imaging study

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Azra Alizad

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azra Alizad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23021305 (View on PubMed)

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.

Reference Type RESULT
PMID: 23475919 (View on PubMed)

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.

Reference Type RESULT
PMID: 22828838 (View on PubMed)

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.

Reference Type RESULT
PMID: 22423235 (View on PubMed)

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.

Reference Type RESULT
PMID: 20113864 (View on PubMed)

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.

Reference Type RESULT
PMID: 18599102 (View on PubMed)

Other Identifiers

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P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000583016

Identifier Type: OTHER

Identifier Source: secondary_id

284-06

Identifier Type: -

Identifier Source: org_study_id

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