Digital Breast Tomosynthesis in Younger Symptomatic Women

May 7, 2018 updated by: Andy Evans, NHS Tayside

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women under 60 years of age with clinical or ultrasound suspicion of breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Digital Breast Tomosynthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of DBT for breast cancer, compared with FFDM
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Accuracy of DBT compared with FFDM in assessment of tumour extent
Time Frame: Two years
Two years
Relative accuracy of DBT and FFDM by breast density
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Tayside

Collaborators

University of Dundee

Investigators

  • Principal Investigator: Andrew J Evans, FRCR, University of Dundee, NHS Tayside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 21, 2016

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 16, 2010

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010ON15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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