Clinical trial NCT06264934: An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner
Official title: An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Benign Breast Disease
Keywords: Breast Cancer
Electrical Capacitance Tomography
Permittivity
Lead sponsor: Zedsen Limited
Sponsor class: INDUSTRY
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2024-02-20
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Participants who are lactating
* Pregnant participants by verbal confirmation
* Participants with pacemakers
* Participants with open breast wound
* Participants who had previous breast surgery (mastectomy, lumpectomy)

Primary outcomes:
measure: Measurement of complex permittivity of breast tissue components
timeFrame: Jan-Nov 2024
Secondary outcomes:
measure: Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)
timeFrame: Jan-Nov 2024
Other outcomes:
measure: Repeatability of the Z-scanner
timeFrame: Jan-Nov 2024
measure: Reproducibility of the Z-scanner
timeFrame: Jan-Nov 2024
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: