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New AI-Powered 'Eye' could slash repeat breast cancer surgeries

NCT ID NCT07111728

Diagnosis Sponsor: Istituti Clinici Scientifici Maugeri SpA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new handheld device that uses light and artificial intelligence to check for leftover cancer cells right after a breast lump is removed. The goal is to help surgeons remove all cancer in one go, avoiding a second surgery. About 104 women having breast-conserving surgery will take part, and the device's results will be compared to standard lab tests.

What this could mean

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

Active substance
Spectra-BREAST system (hyperspectral imaging and Raman spectroscopy device)
What this could lead to
If successful, this device could help surgeons remove all cancer in one surgery, reducing the need for a second operation.
What could go wrong
This is an early-stage study with only 104 participants. The device may not be accurate enough in real-world use, and results may not apply to all breast cancer 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.

Participants

About 104 people

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

Started

Oct 2025

Expected to finish

Dec 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.

Who is studied

All female patients referred consecutively to the Breast Unit at Istituti Clinici Scientifici Maugeri (IRCCS) in Pavia who present with an imaging-detected, clinically non-palpable breast lesion and are scheduled for breast-conserving surgery (lumpectomy).

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: Histologically confirmed diagnosis of ductal carcinoma in situ (B5a) or invasive breast carcinoma (B5b) on pre-operative core needle biopsy Scheduled to undergo breast-conserving surgery (lumpectomy) Able and willing to provide written informed consent Exclusion Criteria: Pre-operative histologic or cytologic diagnosis of a benign breast lesion (B2/C2) Initial diagnosis of advanced (stage III/IV) or metastatic breast carcinoma, or indication for neoadjuvant chemotherapy Neurocognitive disorders that would impair comprehension of the study procedures or consent process Concurrent pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ invasive breast carcinoma

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

    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

  • Istituti Clinici Scientifici Maugeri IRCCS

    RECRUITING

    Pavia, Lombardy, 27100, Italy

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