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Clinical Trials/NCT01241981
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

NHS Tayside1 site in 1 country446 target enrollmentMarch 2011
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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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