Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01593384
Recruitment Status : Withdrawn (Funding unavailable)
First Posted : May 8, 2012
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion detection in dense breasted women. Even though DBT has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. The overlapping of tissue on a standard of care 2D mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that mimic cancers. This leads to patients being asked to come back for additional imaging including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up to 43% in reader studies. Even though these results are promising they were not done in a realistic clinical setting.The purpose of this study is to evaluate the FDA-approved combination standard digital mammography (DM) and DBT technology and its impact on our clinical practice.

Condition or disease
Breast Cancer

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer
Study Start Date : April 2012
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Primary Outcome Measures :
  1. Measure the impact on recall rates, comparing DM and DM+DBT [ Time Frame: 3 yrs ]
    Measure the impact on recall rates, comparing DM and DM+DBT, in our practice and the impact on cancer detection in our screening population.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects from routine clinical patient population at our medical facility. There will be inclusion of employees and students in the study. A number of UHCMC employees and a few CWRU students are in our routine clinical patient population.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01593384

Sponsors and Collaborators
Case Comprehensive Cancer Center
Principal Investigator: Donna Plecha, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT01593384     History of Changes
Other Study ID Numbers: CASE2112
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Case Comprehensive Cancer Center:
Breast Cancer
Digital Breast Tomosynthesis (DBT)
Digital Mammography (DM)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases