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

This study is currently recruiting participants.

Verified June 2012 by University of Pittsburgh

Sponsor:

Information provided by (Responsible Party):

Jules Sumkin, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01106911

First received: April 16, 2010

Last updated: June 19, 2012

Last verified: June 2012

History of Changes

Purpose

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%.

Condition	Intervention
Breast Abnormalities	Device: tomosynthesis and screening mammography

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Mammography

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

recall rates [ Time Frame: upon recruitment/enrollment phase completion ] [ Designated as safety issue: No ]
Recall rates and specificity of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.

Estimated Enrollment:	1080
Study Start Date:	May 2010
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: digital breast tomosynthesis

Detailed Description:

The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.

Eligibility

Ages Eligible for Study:	35 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women between the ages of 34 and 56.
Women presenting for their baseline screening mammography examination

Exclusion Criteria:

Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
Women who may be or are pregnant by self report
Women older than 55 years of age or younger than 35.
Women with known fatty breast tissue
Males and children
Women who are unable to understand or execute written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106911

Contacts

Contact: Linda Lovy, RT(R)(M)(CT), RDMS(BR)

(412)641-6966

lovyls@upmc.edu

Locations

United States, Pennsylvania
Magee-Womens Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Linda Lovy 412-641-6966 lovyls@upmc.edu
Principal Investigator: Jules H Sumkin, DO

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Jules H Sumkin, DO

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Jules Sumkin, Chief of Women's Imaging, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01106911 History of Changes
Other Study ID Numbers:	PRO09060334
Study First Received:	April 16, 2010
Last Updated:	June 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

digital breast tomosynthesis
baseline screening mammography
recall rates

Additional relevant MeSH terms:

Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013

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