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PET/CT Imaging for Anakinra-Induced Amyloidosis in CAPS

This study is testing a new way to find and track amyloidosis (protein clumps) in people with Cryopyrin-Associated Periodic Syndromes (CAPS) who have developed amyloidosis from anakinra treatment. Researchers are using a special tracer called 124I AT-01 with PET/CT scans. This tracer attaches to amyloid, allowing doctors to see where it is in the body, including organs like the kidney, liver, and spleen. The goal is to see if changes in the amount of tracer seen on scans over two years can show how the amyloidosis is changing. You may be able to join if you are 18 or older, have Muckle-Wells syndrome (MWS) or Neonatal Onset Multisystem Inflammatory Disease (NOMID), and are already part of NIH protocol 17-I-0016.

Study design
This is an interventional study planning to enroll 30 participants. It is designed to evaluate the feasibility of using a radiotracer for imaging amyloidosis.
What's involved
You would have PET/CT scans with 124I-AT-01 about every 6 months for 2 years. Blood and urine samples will also be collected for safety checks.
Compensation
Not stated in the trial record.
Follow-up
The study will measure changes in tracer uptake for 2 years and track CAPS disease flares through the end of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06974877

Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure Changes in Organ-Specific Amyloid Load

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
National Institute of Allergy and Infectious Diseases (NIAID)
~30 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:124I AT-01

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in organ-specific 124I AT-01 uptake from baseline PET/CT imaging to the follow up PET/CT imaging every 6 months for 2 years.
Measured over 2 years
+1 more outcome measured

Conditions

Cryopyrin-Associated Periodic Syndromes
Amyloidosis

Explore related trials

AmyloidosisChronic Infantile Neurological Cutaneous and Articular SyndromeMuckle-Wells Syndrome

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Sara Alehashemi, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Sara Alehashemi, M.D.
[email protected]
(000) 000-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Change in organ-specific 124I AT-01 uptake from baseline PET/CT imaging to the follow up PET/CT imaging every 6 months for 2 years.2 years

    The gold standard for detecting amyloid deposits is tissue biopsy. With this compound, we expect to detect evidence of tissue deposits in the tissue at a much earlier stage and in a non invasive manner. By lowering the exposure to anakinra in participants with anakinra-associated systemic amyloidosis, the burden of amyloidosis is expected to reduce over time.

  • Frequency of CAPS disease flares after exposure to 124I AT 01.Through end of study.

    This compound has not been used in patients with CAPS. We will monitor the participants to detect possible inflammatory disease flare following the exposure.