Multicenter Hologic Tomosynthesis Study

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00971087
• Lead Sponsor: Hologic, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2011-09
• Study Completion: 2012-04
• Results First Submitted: 2022-12-08
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Results First Posted: 2025-02-26
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3521

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	At time of exam	ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.

Secondary Outcome Measures

Name	Time	Method
Analysis of ROC Performance in Subjects With Dense Breasts	At time of exam	The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4).; Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference.
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM	at time of exam	The non-cancer recall rate was measured for 3DS and 2D FFDM

Trial Locations

Locations (22)

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

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