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
| NCT ID | NCT06974877 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Cryopyrin-Associated Periodic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2031-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-09-10 with a primary completion date of 2031-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Sara Alehashemi, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT06974877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Cryopyrin-Associated Periodic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06974877 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06974877 currently recruiting?
Yes, NCT06974877 is actively recruiting participants. Contact the research team at sara.alehashemi@nih.gov for enrollment information.
Where is the NCT06974877 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06974877 clinical trial?
NCT06974877 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Sara Alehashemi, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 30 participants.