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OpenTrials
Completed

NCT Number: NCT01241981

Digital Breast Tomosynthesis in Younger Symptomatic Women

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 59 year

Sex eligibility

Female

Study type

Observational

Primary location

NHS Tayside, Ninewells Hospital & Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity of DBT for breast cancer, compared with FFDM

    Time frame: Two years

Secondary outcomes

  1. Accuracy of DBT compared with FFDM in assessment of tumour extent

    Time frame: Two years

  2. Relative accuracy of DBT and FFDM by breast density

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

NHS Tayside

Other Gov

Collaborators

  • University of Dundee

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Nov 16, 2010
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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