An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner (DiCECT)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Benign Breast Disease
• Intervention / Treatment: Device: Breast scan using the Z-scanner; Device: Breast scan using 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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Jessica Lin; Phone Number: +44 (0) 7873930941; Email: jessica@zedsen.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Lesley Honeyfield
    • Principal Investigator: Adrian Lim
    • Sub-Investigator: Deborah Cunningham
    • Sub-Investigator: Sylvie Flais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Breast scan using the Z-scanner; Four repeated scans of both breasts using the Z-scanner.; Device: Breast scan using the Z-scanner; A scan 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.	Device: Breast scan using the Z-scanner; Four repeated scans of both breasts using the Z-scanner.; Device: Breast scan using the Z-scanner; A scan of both breasts using the Z-scanner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)	Jan-Nov 2024

Other Outcome Measures

Outcome Measure	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.	Jan-Nov 2024

Collaborators and Investigators

• Sponsor: Zedsen Limited
• Collaborators: Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Electrical Capacitance Tomography; Permittivity
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: DiCECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No