Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
- Conditions
- Breast Neoplasms
- Registration Number
- NCT02771444
- Lead Sponsor
- Philips Digital Mammography Sweden AB
- Brief Summary
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.
- Detailed Description
Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.
The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 17
- Woman over 40 years of age
- Has a tomosynthesis examination with comparator
- Has a mammographic finding
- Pregnant, breastfeeding or believes she may be pregnant
- Unable or unwilling to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method X-ray dose 4 months X-ray dose will be measured per projection.
- Secondary Outcome Measures
Name Time Method Lesion conspicuity comparison of images from study device vs comparator 4 months Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator
Trial Locations
- Locations (1)
Ospedale San Rafaele
🇮🇹Milan, Italy
Ospedale San Rafaele🇮🇹Milan, Italy