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Tomosynthesis in Screening Mammography

NCT01086241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

  • Breast Density

Interventions

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.

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Aalo Bistritz, MD · Cross Cancer Institute

  • Aalo Bistritz, MD · Cross Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086241 on ClinicalTrials.gov