NCT01241981
Completed
Not Applicable
Digital Breast Tomosynthesis (DBT): Sensitivity for Cancer and Accuracy in Assessing Extent of Malignant Disease in Symptomatic Women Below 60 With Clinical or Ultrasound Signs Compatible With Malignancy
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- NHS Tayside
- Enrollment
- 446
- Locations
- 1
- Primary Endpoint
- Sensitivity of DBT for breast cancer, compared with FFDM
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.
Investigators
Andy Evans
Professor of Breast Imaging
NHS Tayside
Eligibility Criteria
Inclusion Criteria
- •Under 60 years old
- •Clinical or ultrasound suspicion of breast cancer
Exclusion Criteria
- •Unable to give informed consent
- •Obvious advanced breast cancer
- •Obvious medical problems meaning surgery would not be an option
Outcomes
Primary Outcomes
Sensitivity of DBT for breast cancer, compared with FFDM
Time Frame: Two years
Secondary Outcomes
- Relative accuracy of DBT and FFDM by breast density(Two years)
- Accuracy of DBT compared with FFDM in assessment of tumour extent(Two years)
Study Sites (1)
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