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

NCT06264934 | Recruiting

• 1 other identifier: DiCECT
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.
2. 2.Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner.

Conditions

Breast Cancer; Benign Breast Disease

Keywords

Breast Cancer; Electrical Capacitance Tomography; Permittivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)

  Jan-Nov 2024

Other Outcomes (2)

• Repeatability of the Z-scanner

  Jan-Nov 2024

• Reproducibility of the Z-scanner

  Jan-Nov 2024

Study Arms (2)

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

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

Interventions

Breast scan using the Z-scanner DEVICE

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

Part A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zedsen Limited: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Jessica Lin

CONTACT

+44 (0) 7873930941; jessica@zedsen.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 20, 2024
• Study Start: January 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)