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

Breast Abnormalities Clinical Trial

Official title:

Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01106911
• Other study ID #: PRO09060334
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2010
• Last updated: September 24, 2013
• Start date: May 2010

Study information

• Verified date: September 2013
• Source: University of Pittsburgh
• Contact: Linda Lovy, RT(R)(M)(CT), RDMS(BR)
• Phone: (412)641-6966
• Email: lovyls[@]upmc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1080
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Abnormalities

Intervention

Device:
• tomosynthesis and screening mammography
All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recall rates	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.	upon recruitment/enrollment phase completion	No