Tomosynthesis in Screening Mammography

NCT ID: NCT01086241

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-04-30

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.

Conditions

Breast Density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

A: routine 2D mammogram

Subject receives regular 2D mammogram.

Group Type: ACTIVE_COMPARATOR

2D Mammogram

Intervention Type: 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.

B: Routine Mammogram + tomosynthesis

Routine Mammogram and tomosynthesis

Group Type: ACTIVE_COMPARATOR

Tomosynthesis

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aalo Bistritz, MD

Role: STUDY_CHAIR

Cross Cancer Institute

Aalo Bistritz, MD

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute

Locations

Alberta Screen Test

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

DX-TOM-001 25232

Identifier Type: -

Identifier Source: secondary_id

DX-TOM-001 25232

Identifier Type: -

Identifier Source: org_study_id