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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect amyloidosis, a condition where proteins clump together and can affect various organs, in people who have developed this condition after taking the medication anakinra. The researchers want to see if a special tracer (a radioactive dye) used during PET/CT scans can help identify amyloidosis in internal organs without the need for a tissue biopsy. This trial is part of a larger study, and it aims to improve how doctors can find and monitor this condition in patients.

To participate in this study, you need to be an adult aged 18 or older who has been diagnosed with amyloidosis related to anakinra injections. You will need to visit the clinic every six months for two years, where you will receive the tracer and undergo a PET/CT scan, which takes about an hour. Each visit will also include a physical exam, blood tests, and a 24-hour urine sample. It's important to note that if you can become pregnant or can impregnate a partner, you will need to use effective contraception during the study. After each visit, you’ll receive a follow-up phone call to check in on your health.

Gender

ALL

Eligibility criteria

• * 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.