RecruitingNCT06264934

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

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


Sponsor

Zedsen Limited

Enrollment

90 participants

Start Date

Jan 25, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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)

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Interventions

DEVICEBreast scan using the Z-scanner

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

DEVICEBreast scan using the Z-scanner

A scan of both breasts using the Z-scanner.


Locations(1)

Imperial College Healthcare NHS Trust

London, United Kingdom

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NCT06264934


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