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Clinical Trial Summary

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.


Clinical Trial Description

Permittivity is the measure of a material's ability to store electrical energy in the electric field. Different materials are known to have different permittivity including the human body. Research is looking into utilising permittivity differences in the human body to detect cancer. There is a particular focus in breast cancer because it is the most common type of cancer in women globally, and research has shown that permittivity of healthy breast tissue is different to cancer tissue. Furthermore, breast tissue can be easily accessible by non-invasive means and has well-established tools available to support cancer detection. However, results from many studies vary greatly and more research is needed to understand how permittivity can be used in cancer research. Zedsen Limited has developed a permittivity measuring device (Z-scanner) capable of measuring a material's permittivity. The purpose of this study is to establish the permittivity of healthy, benign, and cancer tissue associated with the Z-scanner. 90 women attending a routine screening assessment clinic or a one stop clinic at Charing Cross Hospital will be recruited over the course of a year. The study is split into 2 parts. Part A will recruit 20 participants to assess whether scanner results can be repeated and reproduced by different users and hardware. Part B will recruit 70 participants to assess whether the Z-scanner can differentiate between benign and cancerous lesion. All participants will have both their breasts scanned using the Z-scanner during their routine appointment. This allows us to investigate the ability of the Z-scanner to identify and differentiate benign and cancerous lesions from healthy breast tissue based on permittivity. Results from this study can further our understanding on how permittivity and such devices can be used in cancer research. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06264934
Study type Observational
Source Zedsen Limited
Contact Jessica Lin
Phone +44 (0) 7873930941
Email jessica@zedsen.com
Status Recruiting
Phase
Start date January 25, 2024
Completion date December 2024

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