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To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer


N/A
30 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer


The investigators would like to prospectively measure the impact on recall rates, comparing
DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in
our screening population. This is a two-site study in which all asymptomatic subjects
undergoing the FDA-approved combination standard of care Digital Mammogram and Digital
Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her
own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will
interpret the DM and DBT images. These radiologists will categorize each case as either
dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The
radiologist will initially read the standard of care DM part of the study first and record
their interpretation and final BIRADs category. The same radiologist will then interpret the
DM+DBT combination study and record their final interpretation and BIRADs category. Prior
mammogram studies will be used for comparison when reading the DM and DM+DBT studies.


Inclusion Criteria:



- Female ages 30 and over

- Asymptomatic

- Any ethnic origin

- No contraindication for routine bilateral mammogram

Exclusion Criteria:

- Pregnancy

- Lactating patients

- Breast implants

- Unable to understand and execute written informed consent

- Patient unable to obtain a mammogram while standing without assistance

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Measure the impact on recall rates, comparing DM and DM+DBT

Outcome Description:

Measure the impact on recall rates, comparing DM and DM+DBT, in our practice and the impact on cancer detection in our screening population.

Outcome Time Frame:

3 yrs

Safety Issue:

No

Principal Investigator

Donna Plecha, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE2112

NCT ID:

NCT01593384

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Digital Breast Tomosynthesis (DBT)
  • Digital Mammography (DM)
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065