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

This study is looking at a diagnostic test called Iodine-124 Evuzumitide (AT-01) to better understand systemic amyloidosis (a condition where abnormal proteins build up in organs). The researchers want to see how accurately this test can find amyloidosis in the heart and other organs. They also want to see how the test results relate to how well organs are working. You might be able to join if you are between 40 and 90 years old and have systemic amyloidosis, a specific genetic mutation for transthyretin amyloidosis, multiple myeloma, or monoclonal gammopathy of undetermined significance. The study aims to enroll 150 participants.

Study design
This is a single-center study that plans to enroll 150 participants. It is an interventional study, meaning participants will receive a diagnostic test.
What's involved
You will undergo imaging tests, primarily a PET/MRI scan, or a PET/CT scan if you cannot have an MRI. The primary endpoint is measured at baseline scan.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for diagnostic accuracy is measured at the baseline scan.

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NCT05758493

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

Recruiting
PHASE2Ages 40–90InterventionalDiagnostic
Oregon Health and Science University
~150 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:124I-Evuzamitide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
I-124 evuzamitide diagnostic accuracy
Measured over At baseline scan
Amyloidosis
Transthyretin Amyloidosis
1 sites across 1 states
Oregon1

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  • I-124 evuzamitide diagnostic accuracyAt 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.