Clinical trial NCT00971087: Multicenter Hologic Tomosynthesis Study
Official title: A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
breast cancer screening
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 3521
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.


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

Primary outcomes:
measure: To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
timeFrame: At time of exam
Secondary outcomes:
measure: Analysis of ROC Performance in Subjects With Dense Breasts
timeFrame: At time of exam
measure: Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM
timeFrame: at time of exam
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging Ltd. (SMIL)
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Greenwood Village
country: United States
facility: Invision/Sally Jobe
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Florida
state: Florida
city: Chicago
country: United States
facility: Luthern General - Advocate Health Care
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Jewish
state: Missouri
city: Rochester
country: United States
facility: Elizabeth Wende Breast Clinic
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: York
country: United States
facility: York - Women's Imaging at Apple Hill
state: Pennsylvania
city: Dallas
country: United States
facility: UTSW Center for Breast Care
state: Texas
city: Houston
country: United States
facility: Memorial Hermann/ Memorial City
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Imaging
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: