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Multi-Compression Spot Mammography

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ClinicalTrials.gov Identifier: NCT01372215
Recruitment Status : Terminated (Referral physician no longer available)
First Posted : June 13, 2011
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Breast Diseases

Study Design

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multi-Compression Spot Mammography
Study Start Date : May 2011
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372215


Locations
United States, New York
University Health Care Center (UHCC)
Syracuse, New York, United States, 13202
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

Responsible Party: Kent Ogden, PhD, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01372215     History of Changes
Other Study ID Numbers: SUNYUMU 5907
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases