Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

Breast Cancer Clinical Trial

Official title:

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535678
• Other study ID #: GE 190-001
• Status: Completed
• Phase: N/A
• First received: September 24, 2007
• Last updated: May 13, 2010
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2010
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Observational

Clinical Trial Summary

To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women =18 years or older for screening mammography

• Able and willing to comply with study procedures, and have signed and dated the informed consent form

• The subject is 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.