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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

RecruitingPhase 1Ages 18 Years - 120 YearsAllNational Institute of Allergy and Infectious Dise…
NCT06974877 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 trace

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📋 Eligibility rules (as published)
* 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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What it tests

  • 124I AT-01
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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