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AI-Powered endoscopy aims to spot head and neck cancer earlier

NCT ID NCT07596355

Diagnosis Sponsor: Istituto Italiano di Tecnologia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test artificial intelligence algorithms that analyze video from routine endoscopies of the head and neck. The AI will try to detect, classify (benign vs. malignant), and outline lesions, comparing its performance to doctors and lab results. About 283 adults with suspected or known lesions will participate, but the AI will not influence their treatment.

What this could mean

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

Active substance
artificial intelligence algorithm
What this could lead to
If successful, this could help doctors more accurately detect and classify head and neck lesions during routine endoscopy, potentially improving early diagnosis.
What could go wrong
This is an observational study that does not change patient care yet. The AI may not perform as well in real-world settings or on 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.

Participants

About 283 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Feb 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

The sample size for a single-arm, prospective cohort study, where the same group of patients undergoes testing with an AI model and a human physician and then they are compared with the gold standard reference test (biopsy) was calculated based on information from previous studies

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: * Age \> 18 years * Injury originating from the upper aero-digestive tract * Recording of the video-endoscopic examination * Patient known to undergo a biopsy of the lesion or clinical follow-up for lesion with known biopsy (e.g. laryngeal papillomatosis) or suffering from Reinke's edema (in this pathology, in fact, biopsy is not necessary since the diagnosis is clinical) * Or patients undergoing transoral lesion excision Exclusion Criteria: * Submucosal lesion * Patients with previous operations on the upper aero-digestive tract * Patients with previous radiotherapy of the head and neck district * Poor compliance on endoscopic examination * Unavailability of CADe/CADx or CASe data logging note

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma laryngeal disorder laryngeal papillomatosis leukoplakia neoplasm polyp of vocal cord squamous cell carcinoma upper aerodigestive tract neoplasm

As listed by the trial registrant

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

Head and neck cancer (H&N) Leukoplakia Squamous cell carcinoma Upper aero-digestive tract (UADT) neoplasm Upper aerodigestive tract neoplasms Upper aerodigestivetract cancer Vocal cord disease Vocal fold nodules Vocal fold polyp

How to take part

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

  1. The places running it

    3 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

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16131, Italy

  • UZ Leuven

    Leuven, Flemish Brabant, 3000, Belgium

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