NCT01372215

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

June 10, 2011

Last Update Submit

May 12, 2015

Conditions

Keywords

Breast massBreast lesion

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Men
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Care Center (UHCC)

Syracuse, New York, 13202, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kent Ogden, PhD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 13, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations