A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography
40 Years
69 Years
Female
Breast Density >25%
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:
Interventional
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:
No
Principal Investigator
Aalo Bistritz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cross Cancer Institute
Authority:
Canada: Health Canada
Study ID:
DX-TOM-001 25232
NCT ID:
NCT01086241
Start Date:
May 2010
Completion Date:
Related Keywords:
- Breast Density >25%
- Tomography
- Mammography
- Breast Neoplasms
- Prevention and Control
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