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Tomosynthesis in Screening Mammography

A

AHS Cancer Control Alberta

Status

Completed

Conditions

Breast Density >25%

Treatments

Procedure: Tomosynthesis
Procedure: 2D Mammogram

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01086241
DX-TOM-001 25232

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 patients

Sex

Female

Ages

40 to 69 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

A: routine 2D mammogram
Active Comparator group
Description:
Subject receives regular 2D mammogram.
Treatment:
Procedure: 2D Mammogram
B: Routine Mammogram + tomosynthesis
Active Comparator group
Description:
Routine Mammogram and tomosynthesis
Treatment:
Procedure: Tomosynthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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