Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT05758493
Study Start
Primary Completion
Study Completion
Enrollment
30
Study Type
Interventional
Phase
Phase 2
Interventions
124I-Evuzamitide

Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Primary Outcomes
Measure
Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution
Description

Pearson Correlation Coefficient of ECV (%) and SUV (124I-Evuzamitide) globally and at a per segment basis

Timeframe
At baseline scan
Secondary Outcomes
Measure
Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake
Description

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

Timeframe
At baseline scan
Measure
Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide
Timeframe
During baseline scan and follow up scan
Measure
Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake
Timeframe
During baseline scan and follow up scan
Measure
Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake
Timeframe
During baseline scan and follow up scan
Measure
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
Timeframe
During baseline scan
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.

Conditions
Amyloidosis
Transthyretin Amyloidosis
Study Contact
Name
Ahmad Masri, MD
Role
Contact
Phone
503-418-1964
Email
masria@ohsu.edu
Name
Jessica Cardin, MS PhD
Role
Contact
Phone
503-418-1964
Email
cardin@ohsu.edu
Facility

Oregon Health & Science University
Portland, OR 97239
United States

Contacts
Study Contact
Name
Ahmad Masri, MD
Role
Principal Investigator
Eligibility Criteria

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

Eligibility Minimum Age
18 Years
Eligibility Maximum Age
90 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Adult
Older Adult
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