Actively Recruiting
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-08
30
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Anakinra is a drug used to treat people with certain diseases that affect their immune systems. Sometimes anakinra can cause proteins under the skin to clump together. These clumps are called amyloidosis; they can spread to other organs. The only way to diagnose amyloidosis is to remove a piece of tissue (biopsy). Researchers want to find a way to locate amyloidosis in internal organs using positron emission tomography (PET)/computed tomography (CT). Objective: To test a new tracer used during PET/CT scans in people with amyloidosis. A tracer is a radioactive dye injected into the body. Eligibility: Adults aged 18 years or older with amyloidosis from anakinra injections. They must be enrolled in NIH protocol 17-I-0016. Design: Participants will come to the clinic once every 6 months for 2 years. Each visit will be 1 day. They will have a PET/CT scan with the new tracer at each visit: The tracer will be given through a tube attached to a needle inserted into a vein. The PET/CT scanner is a machine shaped like a doughnut. Participants will lie still on a padded table. The table will move in and out of the machine. The scan takes about 1 hour. Radiation from the tracer will remain in the body for 24 hours after each scan. Participants will need to follow rules to avoid exposing pets and other people. Participants will collect a 24-hour urine sample before each visit. They will also have blood tests and a physical exam at each visit. Participants will receive a follow-up phone call about 1 week after each visit.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and older.
- Currently enrolled on NIH protocol 17-I-0016 with a documented diagnosis of Muckle-Wells syndrome or neonatal onset multisystem inflammatory disease.
- Agree to allow data collected in this study to be shared with and stored on NIH protocol 17-I-0016 for research analyses.
- Developed skin thickening at the site of anakinra injection.
- Participants who can become pregnant or impregnate their partner must agree to use 2 highly effective methods of contraception, including at least 1 barrier method, from 28 days before baseline until 90 days after the last PET/CT scan.
You will not qualify if you...
- Known hypersensitivity to 124I-AT-01, AT-01, or any of their excipients.
- Known hypersensitivity to potassium iodide (KI).
- Pregnant or breastfeeding.
- Currently receiving dialysis.
- Currently taking heparin, low molecular weight heparins, or other blood thinners for anticoagulation.
- Any condition that, in the opinion of the study team, contraindicates participation in this study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sara Alehashemi, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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