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CompletedNCT01241981Updated May 8, 2018

Digital Breast Tomosynthesis in Younger Symptomatic Women

An observational study in Breast Cancer, sponsored by NHS Tayside. Completed at 1 site in United Kingdom. Open to female participants aged Up to 59 Years. Per ClinicalTrials.gov, last updated 2018-05-08.

Sponsored by NHS Tayside · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
446
Ages
Up to 59 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breast Cancer

Keywords

  • Breast
  • Cancer
  • Digital
  • Mammography
  • Tomosynthesis
03

In context

Lead sponsor

NHS Tayside is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 59 Years
Sexes eligible
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

Inclusion criteria

  • Female
  • Under 60 years old
  • Clinical or ultrasound suspicion of breast cancer

Exclusion criteria

Exclusion Criteria:

  • Unable to give informed consent
  • Male
  • Obvious advanced breast cancer
  • Obvious medical problems meaning surgery would not be an option
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
446 participants (actual)

Groups and cohorts

  • Digital Breast Tomosynthesis

    Digital Breast Tomosynthesis

06

What researchers measure

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

07

Study locations

1 site
  • NHS Tayside, Ninewells Hospital & Medical School
    Dundee, Tayside DD1 9SY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01241981
Lead sponsor
NHS Tayside
Collaborators
University of Dundee
Responsible party
Andy Evans (Professor of Breast Imaging, NHS Tayside) — Principal investigator
First posted
Nov 16, 2010
Start date
Mar 2011
Primary completion
Dec 21, 2016
Completion
Feb 28, 2018
Last update
May 8, 2018

Study contacts

Andrew J Evans, FRCR
principal investigator · University of Dundee, NHS Tayside

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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