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AI and PET scans join forces to spot lung trouble in rare muscle disease

NCT ID NCT07531446

Knowledge-focused Sponsor: Ruijin Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at 200 people with dermatomyositis, a rare muscle disease that often affects the lungs. Researchers are using special PET/CT scans and machine learning to create a model that can better predict if a patient has interstitial lung disease. The goal is to improve diagnosis without invasive procedures.

What this could mean

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

What this could lead to
If successful, this could lead to a more accurate, non-invasive way to diagnose lung complications in dermatomyositis patients.
What could go wrong
This is an observational study using existing images, not a treatment trial. The model may not work well in other hospitals or 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

200 people

The number who actually took part.

Started

Jan 2026

Expected to finish

Jan 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

Between June 2023 and July 2025, 154 consecutive patients diagnosed with dermatomyositis (DM) who underwent 68Ga-FAPI-04 PET/CT imaging were initially considered. The diagnosis of DM was established based on Bohan and Peter criteria for classic DM \[24\], or Sontheimer criteria for clinically amyopathic dermatomyositis (CADM)\[25\]. The diagnosis of interstitial lung disease (ILD) was confirmed by a multidisciplinary team based on a combination of clinical symptoms (cough, dyspnea), physical findings (inspiratory crackles), high-resolution computed tomography (HRCT) evidence of interstitial changes, and pulmonary function tests showing restrictive ventilator defects.

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: 1. The diagnosis of dermatomyositis (DM) was made in accordance with the Bohan and Peter criteria 2. The diagnosis of clinically amyopathic dermatomyositis (CADM) was established based on the Sontheimer criteria 3. The diagnosis of interstitial lung disease (ILD) was confirmed in line with the criteria of the American Thoracic Society (ATS) 4. ⁶⁸Ga-FAPI and ¹⁸F-FDG PET/CT scans were performed in the Department of Nuclear Medicine. Exclusion Criteria: Patients with other connective tissue diseases.

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Conditions

The condition(s) this trial relates to.

clinically amyopathic dermatomyositis dermatomyositis interstitial lung disease

As listed by the trial registrant

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

Dermatomyositis (DM) ILD Machine learning Radiomics

Contacts and locations

Locations

  • Department of Nuclear Medicine & Institute for medical imaging technology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.