Cryopyrin-Associated Periodic Syndromes study: 124I AT-01
Official title 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
ClinicalTrials.gov ID: NCT06974877
What this study is testing
What is 124I AT-01?
This is an investigational radioactive dye being studied to help doctors see amyloid deposits in the body using PET/CT scans. It is designed to bind to amyloid proteins so they can be seen on a PET/CT scan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if a radioactive tracer can show where amyloid protein has built up inside the body.
- Who it's for
- Adults 18 years or older who have amyloidosis caused by anakinra and are in NIH protocol 17‑I‑0016.
- What's involved
- You will receive an injection of the tracer, have a PET/CT scan lasting about an hour, give a 24‑hour urine sample, and have blood tests and a physical exam at each visit.
- Time commitment
- Visits occur every six months for two years, each lasting one day, plus a follow‑up phone call about a week later.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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.
- External or internal condom with spermicide.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- External or internal condom with spermicide.
- Diaphragm or cervical cap with a spermicide.
- Hormonal contraception.
- Intrauterine device.
- Hysterectomy, oophorectomy, or tubal ligation in women
- Vasectomy in men
- Other.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.