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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05758493
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amyloidosis
  • Transthyretin Amyloidosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 124I-Evuzamitide — DIAGNOSTIC_TEST
    Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Study Details

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.

Key Dates

Start date
Jan 10, 2023
Status verified
Apr 2026
Primary completion
Dec 10, 2027
Completion
Mar 10, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients with ATTR-CM
    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.

Primary Outcome Measure

I-124 evuzamitide diagnostic accuracy [ Time Frame: At baseline scan ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Ahmad Masri, MD
[email protected]
Ahmad Masri, MD (PRINCIPAL_INVESTIGATOR)

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Oregon Health & Science University· Portland, OR

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