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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00626119
First received: February 28, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: In Vivo Breast Imaging by Vibro-acoustography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Further development of a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: June 2001
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
diseased

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with and without breast masses

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626119

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mostafa Fatemi, PhD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mostafa Fatemi, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00626119     History of Changes
Other Study ID Numbers: 729-01-0, P30CA015083, CDR0000583249
Study First Received: February 28, 2008
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013