Using PET/CT Imaging to Detect Amyloidosis in Patients Treated with Anakinra
A Phase 1 Study of Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using Amyloid-Reactive Peptide 124I-AT-01 (124I-p5+14, Iodine-124I-Evuzamitide) to Measure Changes in Organ-Specific Amyloid Load
This study is testing a new imaging method to see if it can help find amyloidosis in adults with cryopyrin-associated periodic syndromes who have been treated with anakinra.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | Radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06974877 on ClinicalTrials.gov |
What this trial studies
This phase 1 study aims to evaluate the feasibility of a new PET/CT radiotracer, 124I-AT-01, to identify amyloidosis in patients with cryopyrin-associated periodic syndromes (CAPS) who have received anakinra treatment. Participants aged 18 and older will undergo PET/CT scans every six months for two years to monitor changes in amyloid load in various organs. The study will also assess the correlation between the imaging results and clinical features of amyloidosis. Blood and urine samples will be collected for safety analyses, but no specimens will be stored for research purposes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of Muckle-Wells syndrome or neonatal onset multisystem inflammatory disease who have developed amyloidosis from anakinra injections.
Not a fit: Patients who do not have amyloidosis or are not receiving anakinra treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to detect and monitor amyloidosis in patients treated with anakinra, improving patient management.
How similar studies have performed: While the use of PET/CT imaging for amyloidosis detection is established, the specific application of the 124I-AT-01 tracer in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sara Alehashemi, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Sara Alehashemi, M.D.
- Email: sara.alehashemi@nih.gov
- Phone: (000) 000-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.