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.
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.
Known hypersensitivity to 124I-AT-01, AT-01, or any of their excipients.
Known hypersensitivity to KI.
Pregnant or breastfeeding.
Currently receiving dialysis.
Single group
124I AT-01
Drug124I-AT-01 is an amyloid-reactive synthetic 45-L amino acid polypeptide radiolabeled with iodine-124, with a theoretical molecular weight of 4763.6 Da (based on amino acid sequence). The polypeptide, AT-01, is not pharmacologically active. 124I-AT-01 binds many forms of human and murine amyloid and is intended to be a PET imaging agent for the detection of amyloid deposits.
Change in organ-specific 124I AT-01 uptake from baseline PET/CT imaging to the follow up PET/CT imaging every 6 months for 2 years.
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.
Frequency of CAPS disease flares after exposure to 124I AT 01.
This compound has not been used in patients with CAPS. We will monitor the participants to detect possible inflammatory disease flare following the exposure.
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