Breast Neoplasms
Conditions
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.
Interventions
DEVICETomo Assessment
A four-view tomosynthesis examination
Sponsors
Philips Digital Mammography Sweden AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an imaging study. All participants will be imaged using two modalities. All participant data will be deidentified.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman over 40 years of age * Has a tomosynthesis examination with comparator * Has a mammographic finding
Exclusion criteria
* Pregnant, breastfeeding or believes she may be pregnant * Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| X-ray dose | 4 months | X-ray dose will be measured per projection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed