An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner

Trial Title: An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner

NCT ID: NCT06264934

Condition: Breast Cancer
Benign Breast Disease

Conditions: Official terms:
Breast Diseases
Fibrocystic Breast Disease

Conditions: Keywords:
Breast Cancer
Electrical Capacitance Tomography
Permittivity

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Breast scan using the Z-scanner
Description: Four repeated scans of both breasts using the Z-scanner.
Arm group label: Part A

Intervention type: Device
Intervention name: Breast scan using the Z-scanner
Description: A scan of both breasts using the Z-scanner.
Arm group label: Part B

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.

Criteria for eligibility:

Study pop:
20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions

Sampling method: Non-Probability Sample
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)

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Imperial College Healthcare NHS Trust

Address:
City: London
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Lesley Honeyfield

Investigator:
Last name: Adrian Lim
Email: Principal Investigator

Investigator:
Last name: Deborah Cunningham
Email: Sub-Investigator

Investigator:
Last name: Sylvie Flais
Email: Sub-Investigator

Start date: January 25, 2024

Completion date: December 2024

Lead sponsor:
Agency: Zedsen Limited
Agency class: Industry

Collaborator:
Agency: Imperial College Healthcare NHS Trust
Agency class: Other

Source: Zedsen Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06264934