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New scan could reveal hidden organ damage without a biopsy

NCT ID NCT06974877

Diagnosis Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a radioactive tracer called 124I-AT-01 that binds to amyloid clumps in the body. Researchers want to see if PET/CT scans can detect amyloidosis in organs of people with CAPS who developed it from anakinra injections. Thirty adults will be scanned every 6 months for 2 years. The goal is to find a non-invasive way to track amyloid buildup over time.

What this could mean

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

Active substance
124I-AT-01 (a radioactive tracer for PET/CT scans)
What this could lead to
If successful, this could provide a non-invasive way to detect and monitor amyloid deposits in organs, reducing the need for biopsies.
What could go wrong
This is a very early phase 1 study with only 30 participants. The tracer may not reliably detect amyloid changes, and there is a small risk of inflammatory flare in people with CAPS.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Sep 2025

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

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: An individual must meet all the following criteria to be eligible for this study: 1. Aged 18 years and older. 2. Currently enrolled on NIH protocol 17-I-0016 with a documented diagnosis of MWS or NOMID. 3. Agree to allow data collected in this study to be shared with and stored on NIH protocol 17-I-0016 for that study s research analyses. 4. Developed skin thickening at the site of anakinra injection. 5. Participants who can become pregnant or who can impregnate their partner must agree to use 2 highly effective methods of contraception, at least 1 of which must be a barrier method, when engaging in sexual activities that can result in pregnancy, beginning 28 days prior to baseline until 90 days after the last PET/CT scan. Acceptable methods of contraception include the following: 1. Barrier methods: * External or internal condom with spermicide. * Diaphragm or cervical cap with a spermicide. 2. Non-barrier methods: * Hormonal contraception. * Intrauterine device. * Hysterectomy, oophorectomy, or tubal ligation in women * Vasectomy in men 3. Other. EXCLUSION CRITERIA: 1. Known hypersensitivity to 124I-AT-01, AT-01, or any of their excipients. 2. Known hypersensitivity to KI. 3. Pregnant or breastfeeding. 4. Currently receiving dialysis. 5. Currently taking heparin or heparin derivatives (eg, low molecular weight heparins) or other blood thinners for anticoagulation. 6. Any condition that, in the opinion of the study team, contraindicates participation in this study.

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Conditions

The condition(s) this trial relates to.

amyloidosis CINCA syndrome cryopyrin-associated periodic syndrome Muckle-Wells syndrome

As listed by the trial registrant

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

Amyloidosis Cryopyrin-associated periodic syndromes

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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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