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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tracer, 124I AT-01, designed to detect amyloidosis, a condition where protein clumps from the drug anakinra can spread to organs. The trial focuses on using PET/CT scans to identify these clumps without a biopsy. Adults who have developed skin thickening from anakinra injections and are part of a specific NIH study may qualify. Participants will undergo scans and provide samples every six months for two years. This research could lead to easier methods for monitoring amyloidosis in the body. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new tracer.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking heparin or other blood thinners. For other medications, the protocol does not specify if you need to stop them.

What prior data suggests that this tracer is safe for use in PET/CT scans?

Research has shown that 124I-AT-01, a new substance used in PET/CT scans, is being tested for its ability to detect amyloid deposits in the body. This substance specifically attaches to amyloid fibers, enhancing the visibility of these protein clumps in organs.

In studies, 124I-AT-01 effectively detected amyloid in the heart, suggesting potential for identifying amyloidosis in other organs. However, sources do not provide information about side effects or how well people tolerate this substance. As this trial is in an early stage, it primarily focuses on understanding the safety and metabolism of the substance. While 124I-AT-01 appears promising for amyloid detection, the trial will assess its safety for humans. Researchers will closely monitor participants for any issues during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 124I AT-01 because it offers a new way to detect amyloidosis using PET/CT imaging, which could significantly improve diagnosis and monitoring. Unlike current treatments that mainly focus on managing symptoms or slowing disease progression, 124I AT-01 uses a radiotracer that selectively binds to amyloid fibers, providing clear images of amyloid deposits in the body. This targeted imaging approach helps doctors better understand the extent and progression of the disease, potentially leading to more personalized and effective treatment strategies.

What evidence suggests that this PET/CT imaging technique is effective for detecting amyloidosis?

In this trial, participants will undergo PET/CT scans using 124I-AT-01, a special imaging agent that detects amyloidosis, which are protein clumps that can spread to organs. Research has shown that this agent effectively identifies these protein clumps in the hearts of patients with systemic amyloidosis. It specifically attaches to amyloid fibers, enhancing the visibility of these clumps in images. This imaging provides crucial information about the presence and spread of amyloidosis in the body. Early results suggest it can detect amyloidosis in several organs, making it a promising tool for diagnosis and monitoring. ^{1 2 4 6 7}

Who Is on the Research Team?

Sara Alehashemi, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06974877

Study Details | NCT06974877 | Repeat PET/CT Imaging in ... The percent change in quantitative uptake of 124I-AT-01 from baseline to each subsequent scan is expected to correlate with changes in clinical features related ...

2. aiq-solutions.com aiq-solutions.com/wp-content/uploads/2024/06/AIQ-Poster_ACC2022.pdf

124I-AT-01 is a novel PET imaging agent which detects ... Cardiac uptake of 124I-AT-01 was significantly higher in patients with systemic amyloidosis compared to healthy patients. A combination of 124I-AT-01 PET/CT.

3. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=001867-I&&query=Antagonist

Protocol Details 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06974877/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

Repeat PET/CT Imaging in People With CAPS and ... This is a phase 1 study to evaluate the feasibility of an investigational positron emission tomography (PET)/computed tomography (CT) ...

5. attralus.com attralus.com/press-releases/attralus-announces-presentation-of-clinical-data-for-124i-evuzamitide-at-01-a-novel-amyloid-specific-pet-imaging-agent-at-the-28th-annual-scientific-session-of-the-american-society-of-nuclear-card

Attralus Announces Presentation of Clinical Data for 124I- ... AT-01 is a first-in-class pan-amyloid imaging agent capable of detecting diverse types of systemic amyloidosis in multiple organs.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37940323/

Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I ... 124 I-evuzamitide is an amyloid-binding radiotracer capable of detecting cardiac amyloid in patients with high sensitivity.

7. asnc.org asnc.org/news/i-124-evuzamitide-receives-fdas-breakthrough-designation-for-cardiac-amyloidosis-imaging/

I-124 Evuzamitide Receives FDA's Breakthrough ... I-124 Evuzamitide Receives FDA's Breakthrough Designation for Cardiac Amyloidosis Imaging · 'Nuclear Cardiology Is Advancing by Leaps and Bounds'.