Patient-Assisted Compression - Impact on Image Quality and Workflow

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled \[TC\]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.

Key facts

Study ID

NCT03196635

Run by

GE Healthcare

People needed

31

Starts

2017-06-19

Expected to finish

2017-06-29

Last updated by the study team

2018-08-31

Who can join

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

You may qualify if…

• Are women aged 40 years or older;
• Are asymptomatic and scheduled for FFDM screening mammography;
• Have left and right breasts;
• Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
• Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
• Are able and willing to comply with study procedures; and
• Are able and 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 study expected to interfere with study procedures or outcomes;
• Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;
• Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
• Are currently lactating; or
• Have breast implants.

Where it is running

• Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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