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NCT Number: NCT05758493

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

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.

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Key information

Conditions

Amyloidosis Amyloidosis, Hereditary, Transthyretin-Related Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Transthyretin Amyloidosis

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Ahmad Masri, MD

CONTACT

[email protected]

Ahmad Masri, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

124I-Evuzamitide

Diagnostic Test

Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Other names: AT-01

Primary outcomes

  1. I-124 evuzamitide diagnostic accuracy

    Time frame: At baseline scan

    To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, compared to SoC site diagnosis. We will assess:

    • The sensitivity of PET/MRI with 124I-evuzamitide PET/MRI for the diagnosis of cardiac amyloidosis.
    • The specificity of PET/MRI with 124I-evuzamitide for the diagnosis of cardiac amyloidosis.

Secondary outcomes

  1. Quantitative measures

    Time frame: At baseline scan

    To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on quantitative scan interpretation, compared to SoC site diagnosis. We will assess the sensitivity and specificity of various quantitative measures, and evaluate inter- and intra-reader agreement.

  2. Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake

    Time frame: At baseline scan

    Pearson Correlation Coefficient of stage of amyloidosis (Mayo Staging System) and SUV (124I-Evuzamitide)

  3. Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide

    Time frame: During baseline scan and follow up scan

  4. Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake

    Time frame: During baseline scan and follow up scan

  5. Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake

    Time frame: During baseline scan and follow up scan

  6. Proportion of patients with ATTR-CM and MGUS or smoldering myeloma who are correctly classified as ATTR-CM based on 124I-Evuzamitide distribution and uptake

    Time frame: During baseline scan

  7. To evaluate the safety of a single intravenous administration of I-124 evuzamitide.

    Time frame: 7 days from baseline scan

    Incidence of related treatment-emergent (S)AEs from time of study drug administration to Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad Masri, MD

CONTACT

[email protected]

503-418-1964

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Attralus, Inc.
  • Bayer

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 7, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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