Expired Study
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Ann Arbor, Michigan 48109


The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.


Inclusion Criteria: - Females 30 years of age or older. - Dense Breasts. - Has undergone clinical two view mammogram and diagnostic breast imaging evaluation. - Suspicious or palpable mass and scheduled for biopsy. Exclusion Criteria: - Pregnant or lactating women. - Prior personal history of breast cancer. - Prior breast augmentation with implants or silicon injection. male patients. - No two view mammogram as part of breast imaging evaluation. - Breast density of almost entirely fatty/scattered fibroglandular densities.

Study is Available At:

Original ID:

HUM 13236



Secondary ID:

Study Acronym:

Brief Title:

Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

Official Title:

Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts

Overall Status:


Study Phase:

Phase 0



Minimum Age:

30 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Intervention Model: Si

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Alexis V. Nees, M.D.
Principal Investigator
University of Michigan

Study Dates

Start Date:April 2006
Completion Date:October 2013
Completion Type:Actual
Primary Completion Date:October 2013
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 31, 2014
First Received Date:July 23, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Measure of digital tomosynthesis and digital mammography test performance.
Time Frame:3 weeks
Safety Issues:False
Description:Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be

Study Interventions

Intervention Type:Procedure
Name:Breast Tomosynthesis
Description:3D breast imaging
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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