Image Quality Assessment for Screening and Diagnostic Mammography

General Electric (GE)

Status

Completed

Conditions

Breast Health

Treatments

Device: Digital Breast Tomosynthesis

Device: Full Field Digital Mammography

Study type

Interventional

Funder types

Industry

Identifiers

124.03-2015-GES-0004

Details and patient eligibility

About

This study is being conducted to determine the image quality of images using a new investigational medical imaging device.

Enrollment

24 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are women aged 40 years or older (≥40 years old);
Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
Are able to walk without assistive devices;
Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
Are willing to provide written informed consent to participate.

Exclusion criteria

Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
Are currently lactating;
Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).