Philips Digital Breast Tomosynthesis trial for CE markets

Not Applicable

• Conditions: C50.9; Breast, unspecified

• Registration Number: DRKS00008916
• Lead Sponsor: Philips Digital Mammography Sweden AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-23
• Study Completion: 2017-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

Patient is female and 40 years of age or older

- Patient will be undergoing a biopsy for a screening-detected abnormality or after presenting with clinical symptoms (e g palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)
- Patient underwent a 2D mammography (FFDM) in this institution with a Philips MicroDose SI L50 or Philips MicroDose L30 system less than 30 days prior to the day of imaging with the investigational device

Exclusion Criteria

- 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 been part of another clinical trial within last 12 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint<br>The primary endpoint for the study is the proportion of cases for which MicroDose Tomosynthesis is rated as providing for equal or better overall lesion conspicuity compared to FFDM (Full Field Digital Mammography). Evaluation of lesion conspicuity will be based on a 7 point Likert scale.<br>A side by side comparison of the Tomosynthesis reconstructions and the digital 2D mammographies will be performed by 6 independent radiologists.<br>

Secondary Outcome Measures

Name	Time	Method
Additionally the 6 radiologists will indpendently review the Philips MicroDose Tomosynthesis reconstruction and the FFDM images. <br>For each breast the radiologists will provide a BI-RADS score to indicate the most likely outcome based on the appearance of the findings. These scores will be used to estimate the portion of cases correctly diagnosed when compared to ground truth.