Not yet recruitingOBSERVATIONAL

An Investigation Into Dielectric Testing for the Evaluation and Characterisation of Breast Tissue Using a Novel Time-Domain Bioimpedance Tool

This study is investigating a new tool called the ZedScanner. It works by measuring how breast tissue stores electrical energy, which can be different in healthy tissue compared to cancerous tissue. Breast cancer is very common, and finding new, simpler ways to detect it is important. The ZedScanner is a handheld device that has been safely used before. This study aims to check how well it can tell the difference between healthy breast tissue, non-cancerous lumps, and cancerous lumps. Women attending breast appointments will have their breasts scanned with the ZedScanner. Researchers will also look at how it works for women having chemotherapy for breast cancer. The goal is to see if this new technology can help improve breast cancer detection and management in the future.

At a glance

Status

Not yet recruiting

Sponsor

Zedsen Limited

Enrolment target

220

Start

01 Sep 2026

Estimated completion

01 Dec 2028

Breast Cancer Breast - Female

What is this study about?

Breast cancer is a common illness that affects many women. Currently, doctors use tools like mammograms to find it. However, researchers are always looking for new, less invasive ways to detect breast cancer earlier and more easily.

This study is testing a new device called the ZedScanner. This device uses a special technology that measures how different tissues in your body store tiny electrical signals. Think of it like how different materials react to electricity in slightly different ways. It's known that healthy breast tissue and breast cancer tissue behave differently when these electrical signals pass through them. The ZedScanner aims to pick up these tiny differences.

The study wants to find out if the ZedScanner is safe, easy to use, and accurate enough to tell the difference between healthy breast tissue, non-cancerous changes, and cancerous lumps. If successful, this technology could lead to new ways of checking breasts and detecting cancer, potentially making the process quicker and more comfortable for patients. Researchers will also be using artificial intelligence (AI) to help make the ZedScanner even better at its job.

Key takeaways

This study is testing a new device, the ZedScanner, for breast cancer detection.
It works by measuring how breast tissue reacts to small electrical signals.
The aim is to see if it can safely tell the difference between healthy, non-cancerous, and cancerous tissue.
Participation involves having the ZedScanner used on your breast during a routine hospital appointment.
This research could help develop less invasive ways to detect breast cancer in the future.
Your decision to join is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be a woman, aged 18 or older, and able to understand and sign the consent form. You'll be asked to participate if you're already coming in for a breast clinic appointment.

There are some reasons why you might not be able to join. For example, if you've had a biopsy very recently (within 14 days), have breast implants, a pacemaker, or other electronic devices in your body. You also can't take part if you have nipple piercings (unless removed), are pregnant or breastfeeding, have an open wound on your breast, or have had breast surgery like a mastectomy or lumpectomy. If you have any metal markers (like a wire or seed) in your breast, you also can't participate.

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 a woman?
Are you 18 years old or older?
Are you able to understand and sign the consent form in English?
Do you have breast implants, a pacemaker, or other electronic devices in your body (excluding dental fillings)?
Are you currently pregnant or breastfeeding?
Have you had breast surgery (like a mastectomy or lumpectomy) or a biopsy in the last 14 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will happen during an existing breast appointment at Charing Cross Hospital. After your usual scans (like a mammogram or ultrasound) and before any biopsy, a researcher will use the ZedScanner on your breast. This device is handheld and will be gently placed on your skin.

Most participants will have one scan. However, if you have breast cancer and are receiving chemotherapy before surgery (called neoadjuvant chemotherapy), and you agree, you might be asked to have two extra scans over your treatment period. This would be to see how the ZedScanner tracks changes in the tumour during your treatment. At the end, everyone who takes part will be asked to fill in a short questionnaire about their experience with the ZedScanner. The total duration of your involvement will depend on whether you have one scan or the extra scans during chemotherapy.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gathered could help develop better ways to detect breast cancer for future patients. The ZedScanner is considered safe and has been tested before. The main potential risk is that the device might not be accurate in its current form. You might also find the experience a little uncomfortable, but it should not cause pain. Your decision to join is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Imperial College Trust
Verified postcode
London, United Kingdom

Common questions

What is the ZedScanner?

It's a new handheld device that uses gentle electrical signals to check breast tissue and see if it can tell the difference between healthy, non-cancerous, and cancerous areas.

Will the ZedScanner hurt?

No, the ZedScanner is designed to be gentle and safe. It should not cause any pain or discomfort, only a light touch on the skin.

Do I need to do anything special before the scan?

You just need to attend your regular breast clinic appointment. If you have nipple piercings, you'll need to remove them before the scan.

How long will the scan take?

The scan itself is quite quick. The whole process of having the ZedScanner used on you during your appointment should not take too long.

Will I get my results from the ZedScanner?

The results from the ZedScanner are for research purposes. They will not be used for your direct medical care. Your doctor will discuss the results of your usual tests with you.

How to find out more

Rosalynn Austin, PhD, RN, BN, MSc, BSc

rosalynn@zedsen.com +447531785361 Official trial record

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