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OpenTrials
Completed

NCT Number: NCT01086241

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.

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Key information

Conditions

Breast Density Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Screen Test

Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2D Mammogram

Procedure

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.

Tomosynthesis

Procedure

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.

Primary outcomes

  1. Interpretation Time of Scan

    Time frame: Within 1 month of receiving scan

Secondary outcomes

  1. Recall Rates

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

  2. Discomfort Scale

    Time frame: Immediately after the subject receives scan

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Hologic, Inc.

Registry information

Official study title

A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2010
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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