NCT00732433

Brief Summary

The purpose of this study is to develop computer programs to assist radiologists in finding breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on direct digital and film mammograms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
433

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2000

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
11.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

7.9 years

First QC Date

August 7, 2008

Last Update Submit

January 27, 2020

Conditions

Tumors, Breast

Outcome Measures

Primary Outcomes (1)

  • Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography.

    Research scan will be completed at the time of scheduled clinical visit.

Study Arms (1)

digital mammogram

EXPERIMENTAL

Digital mammography is a non-invasive imaging technique to obtain an x-ray image of the breast. Two-view digital mammogram of the breast with a lesion that has been recommended for biopsy during the subject's regular clinical care. The digital mammogram is then analyzed by a computer program.

Procedure: digital mammography

Interventions

digital mammographyPROCEDURE

Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.

digital mammogram

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females who have been scheduled for mammographic exams.
  • Females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram.
  • Females who can give informed consent.

You may not qualify if:

  • No subject under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Heang-Ping Chan, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 12, 2008

Study Start

June 1, 2000

Primary Completion

April 30, 2008

Study Completion

January 1, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

US(1)