NCT01086241

Tomosynthesis in Screening Mammography

A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: Female
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Density

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-03-15
• Last updated: 2025-06-29

Locations

1 site across 1 country: Canada