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Can AI read fused PET and MRI scans to forecast survival in a rare heart disease?

NCT ID NCT07103863

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers at Beijing Anzhen Hospital are studying whether a computer model that combines two types of heart scans can predict 12-month survival in people with light-chain cardiac amyloidosis, a condition where abnormal proteins stiffen the heart. The study enrolls 49 patients who are already receiving standard chemotherapy and heart support. Participants undergo 18F-FAPI PET/CT and 3D cardiac MRI scans at the start and again at six months, and the researchers use machine learning to pull imaging features from the fused scans. The goal is to see if this approach predicts death or hospitalization better than standard blood tests and clinical staging.

What this could mean

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

Active substance
a radiomics model that combines 18F-FAPI PET/CT and 3D cardiac MRI scans
What this could lead to
If it works, doctors could use a single imaging-based tool to estimate how a patient with light-chain cardiac amyloidosis will fare and adjust care earlier.
What could go wrong
This is a small, single-center observational study of 49 people, so the model may not predict accurately in other hospitals or patient groups. It also does not test a new treatment.

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 49 people

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

Started

Feb 2025

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

Study Design 1. Study Type: Single-center prospective cohort study (evaluating the prognostic value of radiomics parameters under standardized treatment). 2. Study Population: Patients with suspected or confirmed cardiac light-chain amyloidosis (AL-CA) via endocardial or extracardiac biopsy who are admitted to the Department of Hematology, Beijing Anzhen Hospital, from Feburary 2025 to August 2028.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Pathologically confirmed AL cardiac amyloidosis (AL-CA) by endocardial biopsy; * Pathologically confirmed AL-CA by extracardiac (bone marrow, adipose tissue, tongue muscle, etc.) biopsy, with serum N-terminal pro-brain natriuretic peptide (NT-proBNP) \> 332 pg/mL, left ventricular mean wall thickness \> 12 mm, and exclusion of hypertension and other secondary causes of left ventricular hypertrophy; * Receiving standard AL-CA treatment regimens (including chemotherapy and supportive therapy). Exclusion Criteria: * Complicated with active infection or advanced malignant tumor (expected survival time \< 12 months); * Presence of severe cognitive impairment, limited mobility, or other conditions that affect compliance with imaging examinations or the completeness of follow-up.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Amyloid Neuropathies, Familial Immunoglobulin Light-chain Amyloidosis

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100029, China

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