Tomosynthesis in Screening Mammography

NCT01086241 | Completed

• 1 other identifier: DX-TOM-001 25232
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Density

Keywords

Tomography; Mammography; Breast Neoplasms; Prevention and Control

Outcome Measures

Primary Outcomes (1)

• Interpretation Time of Scan

  Within 1 month of receiving scan

Secondary Outcomes (2)

• Recall Rates

  6 month intervals for 2 years after initial scan

• Discomfort Scale

  Immediately after the subject receives scan

Study Arms (2)

A: routine 2D mammogram

ACTIVE COMPARATOR

Subject receives regular 2D mammogram.

Procedure: 2D Mammogram

B: Routine Mammogram + tomosynthesis

ACTIVE COMPARATOR

Routine Mammogram and tomosynthesis

Procedure: Tomosynthesis

Interventions

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.

A: routine 2D mammogram

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.

B: Routine Mammogram + tomosynthesis

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior mammogram report indicating \<25% breast density.
• Breast implants
• Pregnancy

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Hologic, Inc.: collaborator

Study Sites (1)

Alberta Screen Test

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Aalo Bistritz, MD

  Cross Cancer Institute

  STUDY CHAIR

• Aalo Bistritz, MD

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

CA (1)