Digital Breast Tomosynthesis in Younger Symptomatic Women
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
1 other identifier
observational
446
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedMay 8, 2018
May 1, 2018
5.8 years
November 15, 2010
May 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity of DBT for breast cancer, compared with FFDM
Two years
Secondary Outcomes (2)
Accuracy of DBT compared with FFDM in assessment of tumour extent
Two years
Relative accuracy of DBT and FFDM by breast density
Two years
Study Arms (1)
Digital Breast Tomosynthesis
Digital Breast Tomosynthesis
Eligibility Criteria
Women under 60 years of age with clinical or ultrasound suspicion of breast cancer
You may qualify if:
- Female
- Under 60 years old
- Clinical or ultrasound suspicion of breast cancer
You may not qualify if:
- Unable to give informed consent
- Male
- Obvious advanced breast cancer
- Obvious medical problems meaning surgery would not be an option
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Taysidelead
- University of Dundeecollaborator
Study Sites (1)
NHS Tayside, Ninewells Hospital & Medical School
Dundee, Tayside, DD1 9SY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Evans, FRCR
University of Dundee, NHS Tayside
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Breast Imaging
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 16, 2010
Study Start
March 1, 2011
Primary Completion
December 21, 2016
Study Completion
February 28, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05