NCT00208871

Brief Summary

The primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,467

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable breast-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

November 19, 2013

Conditions

Breast Cancer

Keywords

Stereoscopic digital mammographyBreast cancer detectionReduced rate of recallFocal abnormalities detection

Outcome Measures

Primary Outcomes (1)

  • sensitivity/specificity

    Aug '04 to Dec '07

Secondary Outcomes (1)

  • Recall rate

    Aug '04 to December '7

Interventions

Stereoscopic Digital MammographyPROCEDURE

screening digital 3D mammogram

Eligibility Criteria

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

You may not qualify if:

  • Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
  • Patient has suspected or confirmed pregnancy,
  • Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

  • Getty DJ, Pickett RM, D'Orsi CJ. Stereoscopic digital mammography: improving detection and diagnosis of breast cancer. In: Computer Assisted Radiology and Surgery (CARS-2001). Berlin, Germany: Elsevier Science B.V., 2001.

    BACKGROUND

  • Getty D. J. Stereoscopic digital mammography. Proceedings of the First Americas Display Engineering and Applications Conference (ADEAC '04), Ft. Worth, 2004, 11-14.

    BACKGROUND

  • Getty, D. J. Stereoscopic and biplane digital radiography. In E. Samei & M. Flynn (Eds.), RSNA Categorical Course in Diagnostic Radiology Physics: Advances in Digital Radiography. RSNA Publications, 2003; 199-209.

    BACKGROUND

  • Getty, D. J. Stereoscopic digital mammography: perceptual and display factors leading to improved early detection of breast cancer. In H-O Peitgen (Ed.), Digital Mammography, IWDM 2002, 6th International Workshop on Digital Mammography. Berlin: Springer, 2003, 431-435.

    RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David J Getty, Ph.D.

    BBN Technologies

    PRINCIPAL INVESTIGATOR

  • Carl J D'Orsi, MD

    Emory School of Medicine Site PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor of Radiology & Hematology/Oncology

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2007

Study Completion

March 1, 2011

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

US(1)