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Digital Breast Tomosynthesis in Younger Symptomatic Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by NHS Tayside.
Recruitment status was:  Recruiting
University of Dundee
Information provided by (Responsible Party):
Liz Coote, NHS Tayside Identifier:
First received: November 15, 2010
Last updated: October 3, 2011
Last verified: October 2011
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.

Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by NHS Tayside:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Digital Breast Tomosynthesis
Digital Breast Tomosynthesis


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01241981

Contact: Andrew J Evans, FRCR +44(0)1382632196
Contact: Patricia J Whelehan, MSc +44(0)1382496426

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

Responsible Party: Liz Coote, R&D Manager, NHS Tayside Identifier: NCT01241981     History of Changes
Other Study ID Numbers: 2010ON15
Study First Received: November 15, 2010
Last Updated: October 3, 2011

Keywords provided by NHS Tayside:
Tomosynthesis processed this record on April 21, 2017