Digital Breast Tomosynthesis in Younger Symptomatic Women

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01241981
• Lead Sponsor: NHS Tayside

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-03
• Primary Completion: 2016-12-21
• Study Completion: 2018-02-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 446

Inclusion Criteria

• Female
• Under 60 years old
• Clinical or ultrasound suspicion of breast cancer

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Exclusion Criteria

• Unable to give informed consent
• Male
• Obvious advanced breast cancer
• Obvious medical problems meaning surgery would not be an option

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of DBT for breast cancer, compared with FFDM	Two years

Secondary Outcome Measures

Name	Time	Method
Relative accuracy of DBT and FFDM by breast density	Two years
Accuracy of DBT compared with FFDM in assessment of tumour extent	Two years

Trial Locations

Locations (1)

NHS Tayside, Ninewells Hospital & Medical School; 🇬🇧 Dundee, Tayside, United Kingdom