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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Twenty healthy participants will be recruited to examine the ability of the Z-scanner to identify healthy breast tissue and assess repeatability and reproducibility of the device. |
| |
| Part B | 70 participants (35 benign and 35 malignant) will be recruited to investigate the ability of the Z-scanner to correctly identify and differentiate malignant and/or benign lesions from healthy breast tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast scan using the Z-scanner | Device | Four repeated scans of both breasts using the Z-scanner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Jan-Nov 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion) | Jan-Nov 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of the Z-scanner | Response voltage signals from raw output of the Z-scanner will be compared between each repeated breast scans. | Jan-Nov 2024 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Lin | Contact | +44 (0) 7873930941 | jessica@zedsen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
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| Breast scan using the Z-scanner | Device | A scan of both breasts using the Z-scanner. |
|
| Jan-Nov 2024 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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