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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
November 15, 2010
November 16, 2010
April 28, 2017
March 2011
December 2012   (Final data collection date for primary outcome measure)
Sensitivity of DBT for breast cancer, compared with FFDM [ Time Frame: Two years ]
Same as current
Complete list of historical versions of study NCT01241981 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Women under 60 years of age with clinical or ultrasound suspicion of breast cancer
Breast Cancer
Not Provided
Digital Breast Tomosynthesis
Digital Breast Tomosynthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
446
July 2017
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
up to 59 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01241981
2010ON15
No
Not Provided
Not Provided
Andy Evans, NHS Tayside
NHS Tayside
University of Dundee
Principal Investigator: Andrew J Evans, FRCR University of Dundee, NHS Tayside
NHS Tayside
April 2017