Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

This study has been completed.

Sponsor:

Information provided by:

GE Healthcare

ClinicalTrials.gov Identifier:

NCT00535327

First received: September 24, 2007

Last updated: May 13, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 24, 2007

Last Updated Date

May 13, 2010

Start Date ^ICMJE

August 2007

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00535327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

Official Title ^ICMJE

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography

Brief Summary

Comparison of the ability of DBT and FFDM to detect breast cancer.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Women referred for diagnostic mammogram

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

220

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography
Able and willing to comply with study procedures, and have signed and dated the informed consent form
Surgically sterile or postmenopausal

Exclusion Criteria:

Pregnant or trying to become pregnant
Has signs or symptoms of breast cancer
Has been previously included in this study
Has breast implants
Has a history of breast cancer and is in active treatment
Has breasts too large to be adequately positioned for the DBT examination

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00535327

Other Study ID Numbers ^ICMJE

GE 190-002

Has Data Monitoring Committee

Responsible Party

GE Healthcare - Kevin Horgan, GE Healthcare

Study Sponsor ^ICMJE

GE Healthcare

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amy Longcore

GE Healthcare

Information Provided By

GE Healthcare

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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