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Trial record 4 of 1538 for:    Open Studies | "Breast Diseases"
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Multi-Compression Spot Mammography

This study is currently recruiting participants.
Verified December 2010 by State University of New York - Upstate Medical University
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01372215
First received: June 10, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

In this study, participants, who are scheduled to have a breast biopsy, will have several extra spot mammogram images taken of the suspicious area. These images will be acquired with varying levels of compression. The images will then be analyzed to determine whether the type of lesion (malignant or benign) can be determined from the image data alone. The biopsy results will be used as a gold standard to determine the true malignancy status


Condition
Breast Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multi-Compression Spot Mammography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women 45 years of age and older who have a suspicious mammagraphy requiring a biopsy

Criteria

Inclusion Criteria:

  • Women 45 years and older
  • Women with suspicious mammography findings requiring a biopsy

Exclusion Criteria:

  • Men
  • Pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372215

Contacts
Contact: Susan Hemingway, BSc 315.464.5099 hemingws@upstate.edu

Locations
United States, New York
University Health Care Center (UHCC) Recruiting
Syracuse, New York, United States, 13202
Contact: Susan Hemingway, BSc     315-464-5099     hemingws@upstate.edu    
Principal Investigator: Kent Ogden, PhD            
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Kent Ogden, PhD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Kent Ogden, PhD, Radiology Department
ClinicalTrials.gov Identifier: NCT01372215     History of Changes
Other Study ID Numbers: SUNYUMU 5907
Study First Received: June 10, 2011
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Breast mass
Breast lesion

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013