Tomosynthesis in Screening Mammography

Not Applicable

Completed

• Conditions: Breast Density >25%
• Interventions: Procedure: Tomosynthesis; Procedure: 2D Mammogram

• Registration Number: NCT01086241
• Lead Sponsor: AHS Cancer Control Alberta

Brief 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.

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-15
• Study Start: 2010-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
• Prior mammogram report indicating ≥ 25% breast density.

Exclusion Criteria

• Prior mammogram report indicating <25% breast density.
• Breast implants
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: Routine Mammogram + tomosynthesis	Tomosynthesis	Routine Mammogram and tomosynthesis
A: routine 2D mammogram	2D Mammogram	Subject receives regular 2D mammogram.

Primary Outcome Measures

Name	Time	Method
Interpretation Time of Scan	Within 1 month of receiving scan

Secondary Outcome Measures

Name	Time	Method
Discomfort Scale	Immediately after the subject receives scan
Recall Rates	6 month intervals for 2 years after initial scan

Trial Locations

Locations (1)

Alberta Screen Test; 🇨🇦 Edmonton, Alberta, Canada