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

Sponsor: Zedsen Limited

NCT ID: NCT06264934

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Breast scan using the Z-scanner (device), Breast scan using the Z-scanner (device)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
Breast scan using the Z-scanner — device: Four repeated scans of both breasts using the Z-scanner. · Breast scan using the Z-scanner — device: A scan of both breasts using the Z-scanner.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
Female
Number of participants
90
Started
2024-01-25
Last checked
2024-06

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • Clinical study - 90 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer
  • • Female only

Where?

  • • London - Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Breast CancerBenign Breast Disease

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What we know so far

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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓Attending a causing symptoms 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 agreement to take part in English

Who cannot take part

  • ✗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
See the full 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)

Where Is This Study? (1 UK site)

Imperial College Healthcare NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Adrian LimPrincipal Investigator

How to Get in Touch

Jessica Lin

Sponsor contact

CONTACT

+44 (0) 7873930941 jessica@zedsen.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-06