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Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

NCT01106911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2016-03-25

Study results available
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Summary

The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

Conditions

  • Breast Abnormalities

Interventions

DEVICE

tomosynthesis and screening mammography

All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Jules H Sumkin, DO · University of Pittsburgh

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106911 on ClinicalTrials.gov