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
  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 NHS Tayside:

Primary Outcome Measures:
  • Sensitivity of DBT for breast cancer, compared with FFDM [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)
Groups/Cohorts
Digital Breast Tomosynthesis
Digital Breast Tomosynthesis

  Eligibility

Ages Eligible for Study:   up to 59 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT01241981

Contacts
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

Locations
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
Investigators
Principal Investigator: Andrew J Evans, FRCR University of Dundee, NHS Tayside
  More Information

No publications provided

Responsible Party: Liz Coote, R&D Manager, NHS Tayside
ClinicalTrials.gov Identifier: NCT01241981     History of Changes
Other Study ID Numbers: 2010ON15
Study First Received: November 15, 2010
Last Updated: October 3, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS Tayside:
Breast
Cancer
Digital
Mammography
Tomosynthesis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 10, 2014