NCT01106911

Brief 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%.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

February 1, 2016

Enrollment Period

4.3 years

First QC Date

April 16, 2010

Results QC Date

January 25, 2016

Last Update Submit

February 24, 2016

Conditions

Breast Abnormalities

Keywords

digital breast tomosynthesisbaseline screening mammographyrecall rates

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Without Cancer Who Were Recalled

    Recall rates 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

Interventions

tomosynthesis and screening mammographyDEVICE

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

Also known as: digital breast tomosynthesis

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Jules H. Sumkin
Organization
University of Pittsburgh
jsumkin@upmc.edu
412-641-1976

Study Officials

  • Jules H Sumkin, DO

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Women's Imaging

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 20, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2014

Last Updated

March 25, 2016

Results First Posted

March 25, 2016

Record last verified: 2016-02

Locations

US(1)