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Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

Sponsor
Hologic, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00754598
Collaborator
(none)
1,183
Enrollment
5
Locations
12
Actual Duration (Months)
236.6
Patients Per Site
19.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.

The resulting images from the this portion of the study were then randomized into a reader study.

The purpose of this clinical study was to compare the 3-D 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 would:

  1. Reduce the recall rate And/or

  2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.

Condition or Disease Intervention/Treatment Phase
  • Device: Tomosynthesis digital mammography imaging system
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1183 participants
Allocation:
Non-Randomized
Primary Purpose:
Diagnostic
Official Title:
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
Actual Study Start Date :
Jul 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

  1. To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images. [10-12 months]

Secondary Outcome Measures

  1. To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. [10-12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Female

  • Any ethnic origin

  • No contraindication for screening mammography

Exclusion Criteria:

  • Significant breast trauma

  • Pregnancy

  • Lactating

  • Breast implants

  • Previous breast cancer

  • Previous surgical biopsy

  • Placement of an internal breast marker

  • Unable to understand and or execute written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale New Haven Hospital New Haven Connecticut United States 06520
2 University of Iowa Medical Center Iowa City Iowa United States 52242
3 Massachusetts General Hospital Boston Massachusetts United States 02116
4 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
5 Magee Women's Hospital Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • Hologic, Inc.

Investigators

  • Principal Investigator: Elizabeth Rafferty, M.D, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00754598
Other Study ID Numbers:
  • 05-01
First Posted:
Sep 18, 2008
Last Update Posted:
Aug 12, 2022
Last Verified:
Sep 1, 2008
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Hologic, Inc.
Breast Cancer
digital mammography
tomosynthesis
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 12, 2022