Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging (DBT)

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: NCT01373671
Recruitment Status : Completed
First Posted : June 15, 2011
Results First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Information provided by (Responsible Party):
Siemens Medical Solutions USA - CSG

Brief Summary:
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on various commercially available Full Field Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.

Condition or disease Intervention/treatment Phase

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 764 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multi-center Case Collection Study to Create a Library of Images From Various Approved Full Field Digital Mammography (FFDM) Systems and 3D Images From Siemens Inspiration Digital Breast Tomosynthesis (DBT) System for Studies in Support of the Inspiration Digital Breast Tomosynthesis Approval
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Mammography exam
Siemens DBT scan
DBT scan

Primary Outcome Measures :
  1. Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone [ Time Frame: 1 year ]
    The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.

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

Inclusion Criteria:

All subjects enrolled into the collection study must:

  • Provide signed informed consent after receiving a verbal and written explanation of the purpose and nature of the study
  • be females, 40 years of age or older at the screening mammographic evaluation or age 30 or older presenting for a biopsy and have one of the following mammograms:

    o Normal cases at screening (BI-RADS® 1, 2 and 3):

    • have a screening mammogram that includes the four standard screening views (RCC, RMLO, LCC and LMLO), as well as have both MLO and CC DBT scans of each breast,

      o Actionable cases at screening (BI-RADS® 0, 4 or 5) with final BI-RADS® 1, 2, 3, 4 or 5:

    • have a screening mammogram with four SSVs and any clinically necessary diagnostic mammographic views, such as straight lateral projections, rolled, magnification view and spot compression views, and, both MLO and CC DBT scans of each breast plus 4 SSVs repeated at the diagnostic or biopsy visit if the screening images are unavailable or were acquired more than 45 days prior to DBT acquisition,
  • have supporting ground-truth documentation for the final BI-RADS® assessment as follows:

    • A one (1) year FFDM follow up without evidence of cancer for normal cases not undergoing biopsy
    • A six (6) or twelve (12) month FFDM follow up confirming benign status for biopsy proven benign cases
    • Pathology report for either benign or malignant biopsy finding

Exclusion Criteria:

Subjects with any of the following conditions or who have had the following procedures will be excluded from this study:

  • Pregnant women or women who believe they may be pregnant or are trying to become pregnant.
  • Mastectomy patients
  • Subjects who have had lumpectomy ≤ 5 years prior to the study entry
  • Inmates (in accordance with 45 CFR 46.306) or mentally disabled individuals
  • BI-RADS® Category 6 (e.g., for which the mammogram was performed for the purpose of planning cancer therapy)
  • BI-RADS® Category 4 or 5 without confirming pathology reports will be considered incomplete
  • Subjects with mammograms that lack the required views or with views judged to be technically inadequate will be considered incomplete and the cases will not be considered for the MRMC reader studies
  • Subjects being accrued from the screening population who know that they will not be in the United States or available for follow up mammograms in one year.

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): NCT01373671

United States, Pennsylvania
Siemens Medical Solutions
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Siemens Medical Solutions USA - CSG

Responsible Party: Siemens Medical Solutions USA - CSG Identifier: NCT01373671     History of Changes
Other Study ID Numbers: SMS-SP09-01
First Posted: June 15, 2011    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: January 13, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Siemens Medical Solutions USA - CSG: