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

Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758493
• Other study ID #: 24299
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: January 2023
• Source: Oregon Health and Science University
• Contact: Ahmad Masri, MD
• Phone: 503-418-1964
• Email: masria[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1)identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 2) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 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

2. Patient willing to consent for the study and undergo the study procedures.

Exclusion Criteria:

1. Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol

2. Has a known allergy to potassium iodide treatment or to gadolinium.

3. Patients on dialysis or those with eGFR <30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI.

4. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration

Related Conditions & MeSH terms

• Amyloidosis
• Transthyretin Amyloidosis

Intervention

Diagnostic Test:
• 124I-Evuzamitide
Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Attralus, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution	Pearson Correlation Coefficient of ECV (%) and SUV (124I-Evuzamitide) globally and at a per segment basis	At baseline scan
Secondary	Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake	Pearson Correlation Coefficient of stage of amyloidosis (Mayo Staging System) and SUV (124I-Evuzamitide)	At baseline scan
Secondary	Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide		During baseline scan and follow up scan
Secondary	Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake		During baseline scan and follow up scan
Secondary	Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake		During baseline scan and follow up scan
Secondary	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		During baseline scan