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

Breast Cancer Clinical Trial

— DiCECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264934
• Other study ID #: DiCECT
• Status: Recruiting
• Start date: January 25, 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Zedsen Limited
• Contact: Jessica Lin
• Phone: +44 (0) 7873930941
• Email: jessica[@]zedsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Breast Disease
• Breast Cancer
• Breast Diseases

Intervention

Device:
• Breast scan using the Z-scanner
Four repeated scans of both breasts using the Z-scanner.
• Breast scan using the Z-scanner
A scan of both breasts using the Z-scanner.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Zedsen Limited	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)		Jan-Nov 2024