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Keywords:
Breast, Experimental, Mammography, Ultrasound, Technology assessment, Cancer
Authors:
N. Ridley1, M. Shere2, I. Lyburn3, P. Bannister2; 1Swindon/UK, 2Bristol/UK, 3Cheltenham/UK
DOI:
10.1594/ecr2017/C-1150
Methods and materials
Clinical:
Patients attending symptomatic clinics at three sites were identified by clinicians as having a palpable lump.
Following informed consent,
eligible patients underwent this prone imaging technique.
The bilateral reconstructed 3D images were correlated with clinical information and other imaging studies including ultrasound and/ or mammography and,
when relevant,
core biopsy results to determine sensitivity scores.
[Ethics approval (Yorkshire & The Humber and South Yorkshire REC 15/YH/0084,
ClinicalTrials.gov NCT02493595)].
Description of the procedure:
Where possible patients had an ultrasound examination and a mammogram as well as cytology or histology (if appropriate and for patient benefit) as part of normal procedure.
Patients were scanned before any surgical or biopsy intervention.
Data collected were BIRADS score,
age and menopausal status,
and breast size.
The subject was required to lie prone with the breast inserted into the ceramic cup lined with a small amount of “contact fluid” of dielectric constant 10.
The scan consisted of checks for goodness of fit of the breast (lack of air gap) and then at least two scans of about 30 seconds each.
The total scan time with patient present was typically less than 5 minutes.
Data collection:
Evaluation consisted of two stages: A judgement of lesion(s) type,
size and location using all available clinical data by a researcher who had no knowledge of the MARIA image,
and,
an assessment of the MARIA image by an engineer who had no access to the clinical data or image.
The two observations were then compared jointly by the two observers to decide on the available data of a good correspondence,
failure to correspond,
or a need to exclude.
In this,
the results from ultrasound with or without mammogram was the “gold standard”.
Equipment:
MARIA is a CE-marked radio-frequency (RF) medical imaging system (9) comprising a patient bed,
a Scanning and Data Processing (SDP) unit which is located under the bed and a touch-screen console featuring a software user interface that controls both acquisition and review.
The SDP unit contains a hemispherical array of 60 RF antenna (figure 1) which encircle the breast and operate in both transmit and receive modes,
resulting in a 3D dataset that records the dielectric properties of the breast.
The breast lies pendant in the array through a hole in the bed and one of a set of conformal ceramic inserts that are placed into the array are provided to fit a range of breast sizes without the need for compression (figure 2).
A coupling fluid which has the consistency of hand moisturiser is applied between the breast and insert to maintain good RF contact.
The scanning procedure comprises a fitting scan and then at least two further scans of around 30 seconds each.
Data is reconstructed as a 3D volume for review.