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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00626119
First received: February 28, 2008
Last updated: June 19, 2012
Last verified: June 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Mostafa Fatemi, PhD Mayo Clinic
  More Information

Additional Information:
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 October 19, 2014