Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.

Key facts

Study ID

NCT02615509

Run by

Philips Digital Mammography Sweden AB

People needed

347

Starts

2016-01-01

Expected to finish

2018-02-20

Last updated by the study team

2020-05-08

Who can join

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

You may qualify if…

• Patient is female and at least 40 years of age
• No contraindication for routine bilateral mammography
• Screening Cohort
• Patient presents for a routine screening mammogram Biopsy Cohort
• Patient is scheduled for a biopsy
• Patient has a screening detected abnormality

You may not qualify if…

• Patient is pregnant or believes she may be pregnant; OR,
• Patient is breast feeding; OR
• Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR,
• Patient has breast implants; OR
• Patient has previous surgical biopsy; OR
• Patient has previous breast cancer; OR
• Patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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