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A Radiation-Free handheld scanner aims to spot breast cancer signatures

NCT ID NCT07782814

Diagnosis Sponsor: Zedsen Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This trial tests a handheld device called the ZedScanner, which measures how breast tissue stores electrical energy—a property that differs between healthy, benign, and cancerous tissue. Around 220 women attending a breast clinic will get an extra, non-invasive scan after routine imaging and before any biopsy. The study aims to see if the device can accurately classify tissue types, and it will also explore how the scanner performs during chemotherapy treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZedScanner, a handheld device that measures electrical capacitance (bioimpedance) in breast tissue
What this could lead to
If it works, this could lead to a non-invasive, radiation-free tool to help detect breast cancer and guide treatment.
What could go wrong
This is an early feasibility study, so the device may not accurately distinguish tissue types. Results will need confirmation in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Eligible people will be identified from those attending their breast clinic appointment who will be having, or had a mammogram or ultrasound, will be identified by a member of the clinical team. Patients eligible for the NACT sub-study may be identified by two routes: first, participants already enrolled in the main DiTECT study whose malignancy is subsequently confirmed and whose clinical plan is to receive standard-of-care neoadjuvant chemotherapy. Second, patients newly diagnosed with invasive breast cancer at the participating site (including those not previously recruited to the main study) who are identified following routine NHS triple assessment, histological confirmation, multidisciplinary team review, and who are scheduled to commence standard-of-care neo-adjuvant chemotherapy. Those who are eligible for the study will only be approached after the cancer diagnosis at which time they will also receive trial documents.

Ages

18 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Attending a breast clinic appointment or other appointment at a participating 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 * Patients who wish to enter the NACT sub-study, inclusion in NACT care is required. Exclusion Criteria: * Participants who have undergone biopsy less than 14 days before the TD-BIS scanner session * Participants with implanted electronics anywhere in the body * 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) * Participants who have breast lesion localisation device (i.e., wire, seed, Magseed) \*Patients who wish to enter the NACT sub-study, there is one additional exclusion criteria: * Participants who have any breast surgery prior to the second scan

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast - female Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Imperial College Trust

    London, W6 8RF, United Kingdom

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