The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:
1. Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts. 2. Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner.
Attending a symptomatic clinic or other appointment at a participating breast clinic site
Assigned female sex at time of birth
Aged 18 years or older at time of scan
Willing, able and mentally competent to read, understand, and provided informed consent in English
Participants who have undergone biopsy less than 14 days before the Z-scanner scan
Participants with implanted electronics
Participants with breast implants
Participants with nipple piercings (unless they are removed prior to the scan)
20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions
Case-only
Prospective
Breast scan using the Z-scanner
DeviceFour repeated scans of both breasts using the Z-scanner.
Breast scan using the Z-scanner
DeviceA scan of both breasts using the Z-scanner.
Measurement of complex permittivity of breast tissue components
Permittivity will be estimated from a series of inter-electrode capacitance derived from raw outputs of the Z-scanner using in house algorithms.
Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)
Repeatability of the Z-scanner
Response voltage signals from raw output of the Z-scanner will be compared between each repeated breast scans.
Reproducibility of the Z-scanner
Response voltage signals from raw output of the Z-scanner will be compared between breast scans obtained by different Z-scanners and different operators.
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Zedsen Limited
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborator
