Digital Breast Tomosynthesis in Younger Symptomatic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241981
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : May 8, 2018
University of Dundee
Information provided by (Responsible Party):
Andy Evans, 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.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 446 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : December 21, 2016
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

Digital Breast Tomosynthesis
Digital Breast Tomosynthesis

Primary Outcome Measures :
  1. Sensitivity of DBT for breast cancer, compared with FFDM [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Accuracy of DBT compared with FFDM in assessment of tumour extent [ Time Frame: Two years ]
  2. Relative accuracy of DBT and FFDM by breast density [ Time Frame: Two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women under 60 years of age with clinical or ultrasound suspicion of breast cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241981

United Kingdom
NHS Tayside, Ninewells Hospital & Medical School
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
NHS Tayside
University of Dundee
Principal Investigator: Andrew J Evans, FRCR University of Dundee, NHS Tayside

Responsible Party: Andy Evans, Professor of Breast Imaging, NHS Tayside Identifier: NCT01241981     History of Changes
Other Study ID Numbers: 2010ON15
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Andy Evans, NHS Tayside: