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

NCT05758493 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24299
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyloidosis; Transthyretin Amyloidosis

Outcome Measures

Primary Outcomes (1)

• I-124 evuzamitide diagnostic accuracy

  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.

  At baseline scan

Secondary Outcomes (7)

• Quantitative measures

  At baseline scan

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

  At baseline scan

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

  During baseline scan and follow up scan

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

  During baseline scan and follow up scan

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

  During baseline scan and follow up scan

Study Arms (1)

Patients with ATTR-CM

EXPERIMENTAL

Patients with ATTR-CM will undergo hybrid 124I-Evuzamitide PET/MRI imaging (or PET/CT) at baseline and in a subgroup, repeat imaging will be performed at an interval of 6-12 months.

Diagnostic Test: 124I-Evuzamitide

Interventions

124I-Evuzamitide DIAGNOSTIC_TEST

Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Also known as: AT-01

Patients with ATTR-CM

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Attralus, Inc.: collaborator
• Bayer: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• Wall JS, Martin EB, Endsley A, Stuckey AC, Williams AD, Powell D, Whittle B, Hall S, Lambeth TR, Julian RR, Stabin M, Lands RH, Kennel SJ. First in Human Evaluation and Dosimetry Calculations for Peptide 124I-p5+14-a Novel Radiotracer for the Detection of Systemic Amyloidosis Using PET/CT Imaging. Mol Imaging Biol. 2022 Jun;24(3):479-488. doi: 10.1007/s11307-021-01681-2. Epub 2021 Nov 16.

  PMID: 34786667 BACKGROUND

MeSH Terms

Conditions

Amyloidosis; Amyloidosis, Hereditary, Transthyretin-Related

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ahmad Masri, MD

CONTACT

503-418-1964; masria@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: March 7, 2023
• Study Start: January 10, 2023
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): March 10, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)