Using PET/CT Imaging to Detect Amyloidosis in Patients Treated with Anakinra

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.