Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment hologic selenia dimensions digital breast tomosynthesis system
Sponsor Hologic, Inc.
Start date September 2009
End date December 2012
Trial size 3800 participants
Trial identifier NCT00971087, 09-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
subjects presenting for a breast biopsy procedure, subject will be imaged before her biopsy procedure with the investigational 2D plus 3D mammography system
hologic selenia dimensions digital breast tomosynthesis system Tomosynthesis
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.
(Other)
subjects presenting for routine asymptomatic mammograms and will then have an investigational 2D plus 3D mammogram
hologic selenia dimensions digital breast tomosynthesis system Tomosynthesis
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 Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Hologic, Inc..