Digital Breast Tomosynthesis in Younger Symptomatic Women

N/ACompletedNCT01241981

NHS Tayside446 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

446

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * Under 60 years old * Clinical or ultrasound suspicion of breast cancer Exclusion Criteria: * Unable to give informed consent * Male * Obvious advanced breast cancer * Obvious medical problems meaning surgery would not be an option

Locations (1)

NHS Tayside, Ninewells Hospital & Medical School

Dundee, Tayside, United Kingdom

Outcomes

Primary Outcomes

Sensitivity of DBT for breast cancer, compared with FFDM

Time frame: Two years

Secondary Outcomes

Accuracy of DBT compared with FFDM in assessment of tumour extent

Time frame: Two years

Relative accuracy of DBT and FFDM by breast density

Time frame: Two years

Data from ClinicalTrials.gov

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