Actively Recruiting
An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner
Led by Zedsen Limited · Updated on 2024-06-07
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zedsen Limited
Lead Sponsor
I
Imperial College Healthcare NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of a new device called the Z-scanner to measure permittivity, which is how well breast tissue stores electrical energy. This observational study focuses on breast cancer and benign breast disease in women, aiming to distinguish healthy, benign, and cancerous breast tissues based on permittivity values. The study also evaluates how consistent and reliable the Z-scanner's measurements are across different users and hardware. The study consists of two parts: Part A will recruit 20 healthy women to test the repeatability and reproducibility of the Z-scanner's measurements, while Part B will include 70 women with either benign or malignant breast lesions to assess the device's ability to differentiate these from healthy tissue. All participants will have both breasts scanned using the Z-scanner during their routine clinic appointments, with multiple scans performed in Part A to verify consistency. Participants will be involved during their regular breast clinic visits, where they will undergo non-invasive scans with the Z-scanner. The researchers will measure complex permittivity values of breast tissue and analyze contrast ratios between lesions and surrounding tissue. The study will monitor these outcomes from January to November 2024. Results will help understand the potential role of permittivity and the Z-scanner in breast cancer detection. The total participation involves a single scan session during routine care, with no long-term follow-up specified.
CONDITIONS
Brief Title
An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 provide informed consent in English
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine clinic appointment
Duration - Single session during routine appointment
Participants have both breasts scanned using the Z-scanner to measure permittivity and assess breast tissue.
1 visit (in-person) coinciding with routine screening or one stop clinic visit
Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
J
Jessica Lin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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