Tomosynthesis in Screening Mammography

AHS Cancer Control Alberta500 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

500

Conditions

Breast Density

Interventions

2D MammogramPROCEDURE

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.

TomosynthesisPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Alberta Screen Test

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Interpretation Time of Scan

Time frame: Within 1 month of receiving scan

Secondary Outcomes

Recall Rates

Time frame: 6 month intervals for 2 years after initial scan

Discomfort Scale

Time frame: Immediately after the subject receives scan

Data from ClinicalTrials.gov

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