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

NCT ID: NCT06264934

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2024-12-31

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.

Conditions

Breast Cancer; Benign Breast Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Breast scan using the Z-scanner

Intervention Type: DEVICE

Four repeated scans of both breasts using the Z-scanner.

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.

Breast scan using the Z-scanner

Intervention Type: DEVICE

A scan of both breasts using the Z-scanner.

Interventions

Breast scan using the Z-scanner

Four repeated scans of both breasts using the Z-scanner.

Intervention Type: DEVICE

Breast scan using the Z-scanner

A scan of both breasts using the Z-scanner.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Zedsen Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jessica Lin

Role: CONTACT

jessica@zedsen.com

+44 (0) 7873930941

Facility Contacts

Lesley Honeyfield

Role: primary

Other Identifiers

DiCECT

Identifier Type: -

Identifier Source: org_study_id