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NCT06974877 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Amyloidosis and Cryopyrin-Associated Periodic Syndromes, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06974877: Recruiting Phase 1 study of Amyloidosis and Cryopyrin-Associated Periodic Syndromes, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06974877 is a Phase 1 study of Amyloidosis and Cryopyrin-Associated Periodic Syndromes that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06974877, a Phase 1 study of Amyloidosis and Cryopyrin-Associated Periodic Syndromes, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The gold standard for detecting amyloid deposits is tissue biopsy. With this compound, we expect to detect evidence of tissue deposits in the tissue at a much earlier stage and in a non invasive manner. By lowering the exposure to anakinra in participants with anakinra-associated systemic amyloidosis, the burden of amyloidosis is expected to reduce over time.
Conditions Studied
Interventions
- DRUG 124I AT-01
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2032-01-31 |
| Phase | Phase 1 |
What NCT06974877 shows while recruiting
NCT06974877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which 124I AT-01 is the first listed.
NCT06974877 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06974877 about?
NCT06974877 is a clinical study titled "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". 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...
What is the current status of trial NCT06974877?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-09-10. Estimated completion is 2032-01-31.
What conditions does trial NCT06974877 study?
This clinical trial studies the following conditions: Amyloidosis, Cryopyrin-Associated Periodic Syndromes.
What interventions are being tested in trial NCT06974877?
The interventions under investigation include: 124I AT-01 (DRUG).
Who is sponsoring clinical trial NCT06974877?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06974877 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06974877's enrollment target sits among peer trials
30 24th of 28 higher than 5 of 28 other Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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