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New 'Touch' test could spot breast cancer faster than biopsy

NCT ID NCT06085833

Diagnosis Sponsor: ARTIDIS AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called ARTIDIS that measures how stiff or soft breast tissue is, which may help doctors tell if a lump is cancerous. About 2,700 people with suspicious breast lesions will have their biopsy tissue tested with this device. The goal is to see if it can accurately diagnose cancer and predict how aggressive it is, compared to standard lab analysis.

What this could mean

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

Active substance
ARTIDIS ART-1 device (nanomechanical phenotype test)
What this could lead to
If successful, this could provide a faster, more accurate way to diagnose breast cancer and predict tumor aggressiveness without relying solely on traditional pathology.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The device's accuracy may not be high enough to replace current methods, and results may vary across different patient groups.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,706 people

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

Started

Nov 2023

Expected to finish

Nov 2035

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.

Ages

18 years and older

Sex

Anyone

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: * Patients aged ≥ 18 years * Ability to understand and the willingness to sign a written informed consent. * Indication for breast biopsy for diagnostic purposes * ECOG performance status of 0 to 3. Exclusion Criteria: * Conditions that, in the investigator's opinion, might indicate that the subject is not suitable for the study.

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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 cancer

How to take part

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

  1. The places running it

    5 sites in 3 countries. 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

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Claraspital

    RECRUITING

    Basel, Basel, CH-4058, Switzerland

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • MD Anderson Cancer Clinic - Mays Clinic

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390-9020, United States

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