Breast Cancer Clinical Trial
— DiCECTOfficial title:
An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner
NCT number | NCT06264934 |
Other study ID # | DiCECT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 25, 2024 |
Est. completion date | December 2024 |
Verified date | June 2024 |
Source | Zedsen Limited |
Contact | Jessica Lin |
Phone | +44 (0) 7873930941 |
jessica[@]zedsen.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Zedsen Limited | Imperial College Healthcare NHS Trust |
United Kingdom,
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 |
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