Tomosynthesis in Screening Mammography

AHS Cancer Control Alberta

Status: Completed

Conditions: Breast Density >25%

Treatments: Procedure: Tomosynthesis; Procedure: 2D Mammogram

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01086241

DX-TOM-001 25232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Female

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

A: routine 2D mammogram

Active Comparator group

Description:

Subject receives regular 2D mammogram.

Treatment:

Procedure: 2D Mammogram

B: Routine Mammogram + tomosynthesis

Active Comparator group

Description:

Routine Mammogram and tomosynthesis

Treatment:

Procedure: Tomosynthesis