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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Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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.