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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: September 24, 2013
Last verified: September 2013
  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:


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 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: tomosynthesis and screening mammography
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
digital breast tomosynthesis
baseline screening mammography
recall rates

ClinicalTrials.gov processed this record on September 16, 2014