Text Size

Multicenter Hologic Tomosynthesis Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00971087
First received: September 2, 2009
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this image acquisition study is to compare, in a Reader Study, the Tomosynthesis System used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone will improve receiver operating characteristic (ROC) area under the curve.


Condition Intervention
Breast Cancer
 Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • To detect a statistically significant increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. The ROC curves will be generated from the probability of malignancy scale, a score of 0% to 100%. [ Time Frame: Fall 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3800
Study Start Date: September 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Biopsy
subjects presenting for a breast biopsy procedure, subject will be imaged before her biopsy procedure with the investigational 2D plus 3D mammography system
 Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Subjects are enrolled from either a screening population or a biopsy population. Both groups 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 recruited in the biopsy population will be imaged on the investigational device prior to their biopsy procedure.
Other Names:
  • Tomosynthesis
  • Tomo
  • Breast tomosynthesis
  • 3D Breast imaging
  • Selenia Dimensions
  • 2D plus 3D breast imaging
screening
subjects presenting for routine asymptomatic mammograms and will then have an investigational 2D plus 3D mammogram
 Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Subjects are enrolled from either a screening population or a biopsy population. Both groups 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 recruited in the biopsy population will be imaged on the investigational device prior to their biopsy procedure.
Other Names:
  • Tomosynthesis
  • Tomo
  • Breast tomosynthesis
  • 3D Breast imaging
  • Selenia Dimensions
  • 2D plus 3D breast imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971087

  Show 22 Study Locations
Sponsors and Collaborators
Hologic, Inc.
  More Information

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT00971087     History of Changes
Other Study ID Numbers: 09-03
Study First Received: September 2, 2009
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hologic, Inc.:
Breast cancer
breast cancer screening

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

ClinicalTrials.gov processed this record on May 23, 2013