ClinicalTrials.gov record NCT05758493

Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age40 years old to 90 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 2 diagnostic imaging study evaluates iodine-124 evuzumitide (AT-01) PET imaging in people with systemic amyloidosis, including transthyretin amyloid cardiomyopathy (ATTR-CM). Participants receive the imaging agent and undergo a baseline hybrid PET/MRI scan (PET/CT if MRI is not possible); some participants may have a repeat scan 6–12 months later. Clinical and imaging data will be collected to compare scan findings with standard clinical diagnosis and organ structure/function.

What it is studying. Whether I-124 evuzumitide PET scans can detect and map amyloid in the heart and other organs; establish diagnostic accuracy for cardiac amyloidosis; characterize extracardiac uptake and distribution in ATTR-CM; and how tracer uptake relates to organ structure and function.

What the researchers hope to learn. Establish diagnostic accuracy of I-124 evuzumitide for cardiac amyloidosis; evaluate extracardiac uptake; map distribution and uptake in ATTR-CM; and correlate tracer uptake with organ structure and function.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 4) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET/MRI). In a subgroup of patients who are unable to undergo PET/MR, computed tomography will be used instead of MRI (i.e. PET/CT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • 124I-Evuzamitide

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance
  • Patient willing to consent for the study and undergo the study procedures.

Exclusion criteria

  • Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol
  • Has a known allergy to potassium iodide treatment or to gadolinium.
  • Patients on dialysis or those with eGFR <30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI.
  • Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive a single intravenous dose of I-124 evuzamitide and undergo a baseline hybrid PET/MRI scan; PET/CT may be used instead if MRI is not possible. In a subgroup, the same imaging may be repeated after 6–12 months. The study team will collect clinical information (demographics, imaging, laboratory data), ask questionnaires such as the Kansas City Cardiomyopathy Questionnaire, and monitor for adverse events for 7 days after administration. Note that gadolinium contrast is used for cardiac MRI when appropriate, and people with related allergies or very low kidney function may be excluded from that part of the protocol.

How the study is structured. Single-group, open-label interventional diagnostic study. Participants receive a single administration of I-124 evuzumitide and undergo hybrid PET/MRI imaging (PET/CT if MRI is not possible). All have a baseline scan; a subgroup may have a repeat scan 6–12 months later. Routine clinical information (demographics, imaging, laboratory data) will be collected alongside the scans.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 10, 2023
Primary completion
Dec 10, 2027 (estimated)
Study completion
Mar 10, 2028 (estimated)
Target enrollment
150 participants (estimated)
Last updated on registry
Apr 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Oregon Health and Science University
Principal investigator
Ahmad Masri, Associate Professor
Oregon Health and Science University
Collaborators
  • Attralus, Inc.
  • Bayer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Oregon Health & Science UniversityRecruiting

    Portland, Oregon, 97239 · United States

Terms used on this page · explanations by MedicalUpdates.ai

positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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