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Digital Breast Tomosynthesis in Younger Symptomatic Women

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241981
First Posted: November 16, 2010
Last Update Posted: April 28, 2017
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.
Collaborator:
University of Dundee
Information provided by (Responsible Party):
Andy Evans, NHS Tayside
  Purpose
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
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 Andy Evans, 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 ]

Enrollment: 446
Study Start Date: March 2011
Estimated Study Completion Date: July 2017
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Digital Breast Tomosynthesis
Digital Breast Tomosynthesis

  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01241981


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

Responsible Party: Andy Evans, Professor of Breast Imaging, NHS Tayside
ClinicalTrials.gov Identifier: NCT01241981     History of Changes
Other Study ID Numbers: 2010ON15
First Submitted: November 15, 2010
First Posted: November 16, 2010
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Andy Evans, NHS Tayside:
Breast
Cancer
Digital
Mammography
Tomosynthesis