Tomosynthesis in Screening Mammography
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography|
- Interpretation Time of Scan [ Time Frame: Within 1 month of receiving scan ] [ Designated as safety issue: No ]
- Recall Rates [ Time Frame: 6 month intervals for 2 years after initial scan ] [ Designated as safety issue: No ]
- Discomfort Scale [ Time Frame: Immediately after the subject receives scan ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: A: routine 2D mammogram
Subject receives regular 2D mammogram.
Procedure: 2D Mammogram
Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
Active Comparator: B: Routine Mammogram + tomosynthesis
Routine Mammogram and tomosynthesis
Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.
|Alberta Screen Test|
|Edmonton, Alberta, Canada|
|Study Chair:||Aalo Bistritz, MD||Cross Cancer Institute|
|Principal Investigator:||Aalo Bistritz, MD||Cross Cancer Institute|