Early Detection of Breast Cancer Using Tomosynthesis Imaging

April 11, 2017 updated by: Duke University
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Not Applicable

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 States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • DUMC Mammography, Duke South Hospital, 2nd floor

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All Subjects accepted for this clinical study must:

  • Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
  • Provide written informed consent
  • Be able to communicate effectively with clinical study personnel.

Exclusion Criteria:

Subjects with any of the following conditions will be excluded from this clinical study:

  • Childbearing potential and subject refuses serum pregnancy test or test result is positive.

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

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tomosynthesis scans
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
Radiation: Mammography and tomosynthesis imaging
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
Other Names:
  • Breast tomosynthesis
  • Digital breast tomosynthesis (DBT)
  • full field digital mammography (FFDM)
  • screen-film mammography
  • film-screen mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
Time Frame: at imaging review by the end of the study, approximately 9 years
at imaging review by the end of the study, approximately 9 years

Collaborators and Investigators

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

Sponsor

Duke University

Investigators

  • Principal Investigator: Joseph Y Lo, PhD, Duke Health

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

November 1, 2004

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00013552
  • 6024 (Other Identifier: DUMC Eirb:Pro00013552)
  • 6503 (Other Identifier: Duke legacy protocol ID)

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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