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Completed

NCT Number: NCT00971087

Multicenter Hologic Tomosynthesis Study

The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–110 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Scottsdale Medical Imaging Ltd. (SMIL), Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Any ethnic origin
  • No contraindication of routine bilateral mammography

Exclusion criteria

  • Any contraindications to mammographic screening, including but not limited to:
  • Significant existing breast trauma
  • Pregnancy
  • Lactating
  • Previous surgical biopsy
  • Previous breast cancer
  • Placement of an internal breast marker
  • Breast implants
  • Unable to understand and execute written informed consent
  • Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure

Treatment and study plan

Hologic Selenia Dimensions Digital Breast Tomosynthesis System

Device

Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.

Other names: Tomosynthesis, Tomo, Breast tomosynthesis, 3D Breast imaging, Selenia Dimensions, 2D plus 3D breast imaging

Primary outcomes

  1. To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.

    Time frame: At time of exam

    ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.

Secondary outcomes

  1. Analysis of ROC Performance in Subjects With Dense Breasts

    Time frame: At time of exam

    The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4).

    Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference.

  2. Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM

    Time frame: at time of exam

    The non-cancer recall rate was measured for 3DS and 2D FFDM

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Official study title

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 3, 2009
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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