Multicenter Hologic Tomosynthesis Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00971087
• Other study ID #: 09-03
• Status: Active, not recruiting
• Phase: N/A
• First received: September 2, 2009
• Last updated: December 5, 2012
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: December 2012
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3800
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Boca Raton Community Hospital	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	University of Virginia	Charlottesville	Virginia
United States	Luthern General - Advocate Health Care	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	UTSW Center for Breast Care	Dallas	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Invision/Sally Jobe	Greenwood Village	Colorado
United States	Memorial Florida	Hollywood	Florida
United States	Memorial Hermann/ Memorial City	Houston	Texas
United States	Intermountain Medical Imaging	Murray	Utah
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	Elizabeth Wende Breast Clinic	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis	Sacramento	California
United States	Scottsdale Medical Imaging Ltd. (SMIL)	Scottsdale	Arizona
United States	Barnes Jewish	St. Louis	Missouri
United States	York - Women's Imaging at Apple Hill	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.		Fall 2010	No