Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women

Breast Cancer Clinical Trial

Official title:

In Vivo Breast Imaging by Vibro-acoustography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626119
• Other study ID #: 729-01-0
• Secondary ID: P30CA015083CDR00
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: June 19, 2012
• Start date: June 2001
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of finding microcalcifications and lesions in the breast.

PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in finding breast microcalcifications and lesions in women.

Description:

OBJECTIVES:

• To further develop a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging.

• To demonstrate and evaluate the capability of VA imaging in detecting microcalcifications and lesions inside the human breast.

OUTLINE: Participants undergo vibro-acoustography (VA) imaging of the breast using ultrasonography over 90 minutes. Participants may also undergo further imaging using clinical ultrasonography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

DISEASE CHARACTERISTICS:

• Meets one of the following criteria:

• Healthy participant

• Proven microcalcifications and/or lesions in the breast

• Hormone status not specified

PATIENT CHARACTERISTICS:

• Female

• Menopausal status not specified

• Not pregnant or nursing

• No condition that does not allow proper use of study imaging devices

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Further development of a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging		one day	No