Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

NCT ID: NCT00535184

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-02-28

Brief Summary

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

Detailed Description

Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Longcore

Role: STUDY_DIRECTOR

GE Healthcare

Other Identifiers

GE 190-003

Identifier Type: -

Identifier Source: org_study_id