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Trial record 1 of 1 for:    NCT01373671
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Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging (DBT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Siemens Medical Solutions USA - CSG
ClinicalTrials.gov Identifier:
NCT01373671
First received: June 13, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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 Intervention
Digital Breast Tomosynthesis
Device: SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Siemens Medical Solutions USA - CSG:

Primary Outcome Measures:
  • efficacy [ Time Frame: screening, 6 months or 1 Year ] [ Designated as safety issue: No ]

Enrollment: 765
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: DBT Device: SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM
DBT scan

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373671

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

No publications provided

Responsible Party: Siemens Medical Solutions USA - CSG
ClinicalTrials.gov Identifier: NCT01373671     History of Changes
Other Study ID Numbers: SMS-SP09-01
Study First Received: June 13, 2011
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Siemens Medical Solutions USA - CSG:
Mammography
Screening
Diagnostic

ClinicalTrials.gov processed this record on November 20, 2014