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Identification and Differentiation of Breast Masses by Vibro-Acoustography


N/A
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Identification and Differentiation of Breast Masses by Vibro-Acoustography


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Known breast mass identified as BI-RADS 4 or 5

- Patients with proven breast cancer who are undergoing chemotherapy before
surgery are eligible

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

5 to 10 minutes for Breast VA imaging

Safety Issue:

No

Principal Investigator

Azra Alizad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

284-06

NCT ID:

NCT00627614

Start Date:

March 2006

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905