PET/CT Imaging for Amyloidosis

Overseen By Sara Alehashemi, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Dialysis, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sara Alehashemi, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

Adults 18+ with amyloidosis from anakinra injections, already enrolled in NIH protocol 17-I-0016. Participants will visit the clinic every 6 months for two years to undergo PET/CT scans using a new tracer to detect amyloid clumps in organs.

Inclusion Criteria

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

Participants who can become pregnant or 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 barrier methods (external or internal condom with spermicide, diaphragm or cervical cap with a spermicide) and non-barrier methods (hormonal contraception, intrauterine device, hysterectomy, oophorectomy, or tubal ligation in women, vasectomy in men, other)

I am part of NIH study 17-I-0016 and have MWS or NOMID.

Exclusion Criteria

Known hypersensitivity to KI

Pregnant or breastfeeding

Any condition that, in the opinion of the study team, contraindicates participation in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Baseline Assessment

Participants undergo initial PET/CT scan with 124I-AT-01 to establish baseline amyloid load

1 day

1 visit (in-person)

Follow-up Imaging

Participants receive PET/CT scans every 6 months to monitor changes in organ-specific amyloid load

2 years

4 visits (in-person, every 6 months)

Safety Monitoring

Participants are monitored for safety and potential CAPS disease flares after each PET/CT scan

2 years

Treatment Details

Interventions

• 124I AT-01

Trial Overview The trial is testing a radioactive dye (124I AT-01) used as a tracer during PET/CT scans to locate amyloidosis without needing tissue biopsies. The process involves injecting the tracer and scanning with PET/CT technology.

Participant Groups

Group I: Interventional Experimental Treatment 1 Intervention

Participants aged 18 years and older with anakinra-type amyloidosis (n=10) will be recruited from NIH protocol 17-I-0016. Upon confirmation of eligibility, they will undergo a PET/CT scan with the investigational radiotracer 124I-AT-01, which selectively binds to amyloid fibers. Blood and urine will also be collected for clinical and research analyses, including measurement of IL-1RA and other biomarkers. These scans and sample collections will be repeated about once every 6 months for 2 years.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+