The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
800
After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to determine their corresponding MARIA® cup insert size. Once this has been determined, participants will be required to lie prone with their breast pendent through an aperture in the MARIA® patient bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts, and array are brought into contact with the breast. Depending on the patient's breast size, one or more cup inserts may be placed in the array to ensure a good but non-compressing fit between the breast and the system interface. The scan sequence will then be performed, this takes a couple of minutes.
North Devon Breast Screening Service- In Health
Exeter, United Kingdom
RECRUITINGThe creation of the required dataset to develop the breast density classification algorithm
Dataset of information containing ground truth breast density from mammogram
Time frame: 12 months
The creation of that algorithm
Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth
Time frame: 12 months
The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score
Analyse the values obtained from both the MARIA algorithm and the mammographic ground truth, and look for correlation using the Boyd percentage score of breast density.
Time frame: 12 months
Understand participant acceptability of the MARIA® scan
Using a specially-designed patient questionnaire, analyse feedback on the MARIA scan experience using a scale from Very acceptable-Acceptable-Neither acceptable or unacceptable-Unacceptable-Very unacceptable.
Time frame: 12 months
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