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A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

40 Years
69 Years
Open (Enrolling)
Breast Density >25%

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Trial Information

A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Interpretation Time of Scan

Outcome Time Frame:

Within 1 month of receiving scan

Safety Issue:


Principal Investigator

Aalo Bistritz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cross Cancer Institute


Canada: Health Canada

Study ID:

DX-TOM-001 25232



Start Date:

May 2010

Completion Date:

Related Keywords:

  • Breast Density >25%
  • Tomography
  • Mammography
  • Breast Neoplasms
  • Prevention and Control