search
Back to results

Multicenter Hologic Tomosynthesis Study

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Sponsored by
Hologic, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, breast cancer screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Scottsdale Medical Imaging Ltd. (SMIL)
  • Hoag Memorial Hospital
  • UC Davis
  • Invision/Sally Jobe
  • Boca Raton Community Hospital
  • Memorial Florida
  • Luthern General - Advocate Health Care
  • Massachusetts General Hospital
  • Spectrum Health
  • Mayo Clinic
  • Barnes Jewish
  • Elizabeth Wende Breast Clinic
  • University of Cincinnati
  • University Hospitals Case Medical Center
  • Albert Einstein Medical Center
  • Magee Women's Hospital
  • York - Women's Imaging at Apple Hill
  • UTSW Center for Breast Care
  • Memorial Hermann/ Memorial City
  • Intermountain Medical Imaging
  • Fletcher Allen Health Care
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Biopsy

screening

Arm Description

subjects presenting for a breast biopsy procedure, subject will be imaged before her biopsy procedure with the investigational 2D plus 3D mammography system

subjects presenting for routine asymptomatic mammograms and will then have an investigational 2D plus 3D mammogram

Outcomes

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%.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2009
Last Updated
December 5, 2012
Sponsor
Hologic, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00971087
Brief Title
Multicenter Hologic Tomosynthesis Study
Official Title
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hologic, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, breast cancer screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy
Arm Type
Other
Arm Description
subjects presenting for a breast biopsy procedure, subject will be imaged before her biopsy procedure with the investigational 2D plus 3D mammography system
Arm Title
screening
Arm Type
Other
Arm Description
subjects presenting for routine asymptomatic mammograms and will then have an investigational 2D plus 3D mammogram
Intervention Type
Device
Intervention Name(s)
Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Other Intervention Name(s)
Tomosynthesis, Tomo, Breast tomosynthesis, 3D Breast imaging, Selenia Dimensions, 2D plus 3D breast imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Scottsdale Medical Imaging Ltd. (SMIL)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Invision/Sally Jobe
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Memorial Florida
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Luthern General - Advocate Health Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes Jewish
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Elizabeth Wende Breast Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45912
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Magee Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
York - Women's Imaging at Apple Hill
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
UTSW Center for Breast Care
City
Dallas
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Facility Name
Memorial Hermann/ Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Intermountain Medical Imaging
City
Murray
State/Province
Utah
ZIP/Postal Code
84175
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Multicenter Hologic Tomosynthesis Study

We'll reach out to this number within 24 hrs