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AI spots hidden spine breaks on routine scans

NCT ID NCT06449742

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study will test whether an AI program can find vertebral fractures (broken spine bones) that might be missed on CT scans done for other reasons. Researchers will look at scans from 250 men aged 50 or older to see how common these fractures are. The goal is to improve detection of osteoporosis-related fractures without extra radiation or cost.

What this could mean

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

Active substance
AI software (NanoxAIHealthVCF) and automatic 3D reconstruction
What this could lead to
If successful, this could make it easier to spot hidden spine fractures on routine CT scans, helping doctors diagnose osteoporosis earlier without extra tests.
What could go wrong
This is an early observational study, not a treatment trial. The AI may not work as well in real-world settings or for all patients, and it won't directly improve health.

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 250 people

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

Started

Mar 2025

Expected to finish

Mar 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.

Who is studied

Male patients, with an age ≥ 50 years old, that perform CT scan, without osteo-metabolic conditions.

Ages

50 years and older

Sex

Male participants only

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. Male subjects 2. Age ≥ 50 years 3. Clinical and medical history data available at abdomen-chest CT evaluation 4. Signature of informed consent to the study Exclusion Criteria: 1. Hospitalized patients 2. Patients known to have osteo-metabolic diseases. 3. with primary and/or acquired immunodeficiency states, and/or severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacute/compensated chronic diseases; moderate-severe renal failure) 4. Patients unable to understand and sign the Informed Consent.

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Conditions

The condition(s) this trial relates to.

osteoporosis spinal fracture

As listed by the trial registrant

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

Osteoporosis Vertebral fracture

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

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy, 20132, Italy

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