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Light may replace needle for breast cancer diagnosis

NCT ID NCT06857669

Diagnosis Sponsor: Region Skane 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether special light-based scans (photoacoustic imaging and diffuse reflectance spectroscopy) can tell the difference between healthy, benign, and malignant breast tissue. Researchers will scan 90 women with known breast lumps and compare the scan results to standard tissue analysis. If the optical technique works, it could offer a faster, painless way to diagnose breast cancer.

What this could mean

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

Active substance
Diffuse reflectance spectroscopy and photoacoustic imaging
What this could lead to
If successful, this could lead to a non-invasive, radiation-free way to diagnose breast cancer, reducing the need for biopsies.
What could go wrong
This is an early-stage diagnostic study with only 90 participants. The technique may not be accurate enough to replace standard biopsy, and results may not apply to all breast types.

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 90 people

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

Started

Dec 2020

Expected to finish

May 2027

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

Accepted

You do not need to have the condition being studied to take part.

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: * solitary malignant or benign biopsy verified tumour \> 1 cm * understands written and oral Swedish Exclusion Criteria: * previous breast surgery * has received neoadjuvant chemotherapy * skin burns in on the chest

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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 tumors Healthy 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

  • Skane University Hospital

    RECRUITING

    Malmö, 20502, Sweden

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