Multicenter Hologic Tomosynthesis Study

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00971087

Run by

Hologic, Inc.

People needed

3521

Starts

2009-09-01

Expected to finish

2012-04-01

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older, up to 110. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Any ethnic origin
• No contraindication of routine bilateral mammography

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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