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

Early Phase 1

Completed

• Conditions: Breast Abnormalities; Breast Neoplasms

• Registration Number: NCT00722059
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measure of digital tomosynthesis and digital mammography test performance.	3 weeks	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 recorded for each image sets.

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States