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Multicenter Hologic Tomosynthesis Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Hologic, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971087
First Posted: September 3, 2009
Last Update Posted: December 6, 2012
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.
Information provided by (Responsible Party):
Hologic, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00971087


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

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT00971087     History of Changes
Other Study ID Numbers: 09-03
First Submitted: September 2, 2009
First Posted: September 3, 2009
Last Update Posted: December 6, 2012
Last Verified: December 2012

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

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