Status:
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cryopyrin-Associated Periodic Syndromes
Amyloidosis
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
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 ca...
Detailed Description
Study Description: This is a phase 1 study to evaluate the feasibility of an investigational positron emission tomography (PET)/computed tomography (CT) radiotracer, 124I-AT-01, to screen for anakinr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- An individual must meet all the following criteria to be eligible for this study:
- Aged 18 years and older.
- Currently enrolled on NIH protocol 17-I-0016 with a documented diagnosis of MWS or NOMID.
- 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.
- Developed skin thickening at the site of anakinra injection.
- 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:
- Barrier methods:
- External or internal condom with spermicide.
- Diaphragm or cervical cap with a spermicide.
- Non-barrier methods:
- Hormonal contraception.
- Intrauterine device.
- Hysterectomy, oophorectomy, or tubal ligation in women
- Vasectomy in men
- Other.
- EXCLUSION CRITERIA:
- Known hypersensitivity to 124I-AT-01, AT-01, or any of their excipients.
- Known hypersensitivity to KI.
- Pregnant or breastfeeding.
- Currently receiving dialysis.
- Currently taking heparin or heparin derivatives (eg, 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.
Exclusion
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2032
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06974877
Start Date
September 10 2025
End Date
January 31 2032
Last Update
September 15 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892