NCT00637598

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 13, 2017

Status Verified

July 1, 2014

Enrollment Period

8.8 years

First QC Date

March 12, 2008

Last Update Submit

April 11, 2017

Conditions

Breast Neoplasms

Keywords

Diagnostic ImagingMammographyBreast Tomosynthesis

Outcome Measures

Primary Outcomes (1)

  • Radiologist ROC (receiver operating characteristic) area under curve (AUC)

    at imaging review by the end of the study, approximately 9 years

Study Arms (1)

Tomosynthesis scans

EXPERIMENTAL

This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.

Radiation: Mammography and tomosynthesis imaging

Interventions

Mammography and tomosynthesis imagingRADIATION

All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).

Also known as: Digital breast tomosynthesis (DBT), Breast tomosynthesis, full field digital mammography (FFDM), screen-film mammography, film-screen mammography
Tomosynthesis scans

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DUMC Mammography, Duke South Hospital, 2nd floor

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Joseph Y Lo, PhD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 18, 2008

Study Start

November 1, 2004

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

April 13, 2017

Record last verified: 2014-07

Locations

US(1)