Image Quality Assessment for Screening and Diagnostic Mammography

Completed · Not applicable

Conditions studied: Breast Health

In brief

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

Key facts

Study ID

NCT02786004

Run by

GE Healthcare

People needed

24

Starts

2016-02-01

Expected to finish

2016-05-01

Last updated by the study team

2018-11-07

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Carolina Breast Imaging Specialist — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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