RecruitingOBSERVATIONAL

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

This research is looking at a new device called the Z-scanner. The main idea is to see if this scanner can find and tell the difference between healthy breast tissue, harmless lumps (benign breast disease), and breast cancer. It does this by measuring how well breast tissue stores electrical energy, a property called 'permittivity'. Scientists know that cancerous tissue often has different electrical properties than healthy tissue. If successful, this Z-scanner could offer a new way to check for breast changes. The study will also test how reliable the scanner is and if different operators get the same results. In total, 90 women will take part, having their breasts scanned during their regular appointments.

At a glance

Status

Recruiting

Sponsor

Zedsen Limited

Enrolment target

Start

25 Jan 2024

Estimated completion

01 Dec 2024

Breast Cancer Benign Breast Disease

What is this study about?

This study is investigating a new type of scanner, called the Z-scanner, which acts a bit like a camera that sees electrical properties inside the body. Scientists know that different parts of the body, including healthy and unhealthy breast tissue, store electrical energy differently. They are particularly interested in breast cancer because it's very common, and research suggests that cancerous breast tissue has different electrical properties compared to healthy tissue. If we can use these differences, it could lead to new ways to detect breast cancer early.

The Z-scanner is designed to measure these electrical properties, which are sometimes called 'permittivity'. The main goal is to find out what these measurements look like in healthy breast tissue, in harmless lumps (called 'benign lesions'), and in cancerous lumps. They also want to make sure the scanner gives consistent results, meaning it works the same way each time it's used and no matter who is using it.

This research is important because current methods for detecting breast changes are well-established, but new, non-invasive (meaning it doesn't involve needles or surgery) tools could make detection even better. By understanding more about these electrical properties and how the Z-scanner works, we could potentially improve how doctors find and understand breast conditions in the future.

Key takeaways

This study is testing a new, non-invasive scanner for breast conditions.
It aims to tell the difference between healthy tissue, harmless lumps, and cancer.
Research participants will have an extra scan during their routine clinic visit.
The scanner uses electrical properties of breast tissue for detection.
There are specific requirements for who can and cannot join the study.

Who may be eligible?

To join this study, you need to be a woman who was assigned female at birth and is 18 years old or older. You should be attending a breast clinic appointment at Charing Cross Hospital where the study is taking place. It's important that you can understand and agree to take part in English.

There are some reasons why you wouldn't be able to join. For example, if you've had a breast biopsy in the last two weeks, have breast implants, a pacemaker, other implanted electronic devices, or an open wound on your breast, you wouldn't be suitable. If you have nipple piercings, they would need to be removed for the scan. Pregnant or breastfeeding women, and those who have had previous breast surgery like a mastectomy or lumpectomy, also cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female and aged 18 or older?
Do you have a scheduled appointment at the breast clinic at Charing Cross Hospital?
Do you NOT have breast implants, a pacemaker, or other electronic devices inside you?
Have you NOT had a breast biopsy in the last 14 days or recent breast surgery?
Are you NOT pregnant or breastfeeding?
Can you understand and give consent in English?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't need any extra appointments beyond your usual clinic visit. During your routine appointment for breast screening or a clinic visit, both of your breasts will be scanned using the Z-scanner. This scan will happen at the same time as your regular check-up. The researchers will simply be gathering information during this scan to understand how the Z-scanner works. You won't receive individual results from the Z-scanner right away. The total duration of your involvement will just be the time it takes for this one scan during your appointment.

Potential risks and benefits

This study has potential benefits by helping to explore a new way to detect breast conditions, which could improve diagnosis in the future. The Z-scanner is non-invasive, meaning it doesn't involve radiation, injections, or surgery. As it's an observational study, the risks are expected to be very low, similar to those of simply attending a clinic appointment. There are no direct personal benefits to you from taking part, as the Z-scanner results won't be used for your immediate diagnosis. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the Z-scanner?

It's a new device being tested that measures electrical properties in breast tissue to see if it can help detect healthy tissue, harmless lumps, and cancer.

Will I get my results from the Z-scanner?

No, the results from the Z-scanner in this study are for research purposes only and will not be given to you or used for your diagnosis at this time.

How long will the scan take?

The Z-scanner scan will be done during your regular appointment and should not add much extra time to your visit.

Is the Z-scanner safe?

Yes, the Z-scanner is a non-invasive device, meaning it doesn't involve radiation, injections, or surgery, so risks are expected to be very low.

Do I have to do anything special before the scan?

If you have nipple piercings, you'll need to remove them before the scan. Otherwise, no special preparation is needed.

How to find out more

Jessica Lin

jessica@zedsen.com +44 (0) 7873930941 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.