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New scanner uses light and sound to spot breast tumors without needles

NCT ID NCT07492589

Diagnosis Sponsor: Franciscus Gasthuis & Vlietland (Hospital) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the Photo-Acoustic Imager 3+ (PAM3+) that uses light and sound waves to create images of breast tissue. The goal is to see how well it can find both benign and malignant breast lesions in women referred to a breast clinic. About 180 women will take part, and the results could help reduce the need for biopsies in the future.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

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

Started

Feb 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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: 1. Women 2. Age \> 18 years 3. Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion 4. Patients who are fully competent to give written informed consent 5. Sufficient knowledge of the Dutch language to complete a questionnaire Exclusion Criteria: 1. Currently undergoing chemotherapy 2. Discharge from the nipple(s) 3. Breast ulcers or -wounds 4. Currently suffering from mastitis 5. Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO) 6. Irremovable piercings on/in the breast 7. Pregnancy 8. Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup) 9. Currently using medication that increases photo-toxicity of the skin or skin care products that increase photosensitivity (e.g. certain antibiotics: tetracyclines or quinolones, certain antidiuretics 10. A history of photosensitive disease (e.g. porphyria, lupus erythematosus) 11. Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease 12. Currently undergoing phototherapy 13. Patients with a known allergy for PVC 14. Patients that are not physically capable of climbing on the examination bed 15. Patients that are not physically capable of laying on the examination bed during the measurements

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Conditions

The condition(s) this trial relates to.

breast benign neoplasm breast cancer

As listed by the trial registrant

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

Benign breast lesions Malignant breast tumours

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

  • Franciscus Vlietland Ziekenhuis

    RECRUITING

    Schiedam, South Holland, 3118 JH, Netherlands

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