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Digital Breast Tomosynthesis in Younger Symptomatic Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by NHS Tayside.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Dundee
Information provided by (Responsible Party):
Liz Coote, NHS Tayside
ClinicalTrials.gov Identifier:
NCT01241981
First received: November 15, 2010
Last updated: October 3, 2011
Last verified: October 2011

November 15, 2010
October 3, 2011
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Relative accuracy of DBT and FFDM by breast density [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
 
Recruiting
200
March 2013
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
Female
up to 59 Years
No
Contact: Andrew J Evans, FRCR +44(0)1382632196 a.z.evans@dundee.ac.uk
Contact: Patricia J Whelehan, MSc +44(0)1382496426 p.j.whelehan@dundee.ac.uk
United Kingdom
 
NCT01241981
2010ON15
No
Liz Coote, NHS Tayside
Liz Coote
University of Dundee
Principal Investigator: Andrew J Evans, FRCR University of Dundee, NHS Tayside
NHS Tayside
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP