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NCT05758493 · ClinicalTrials.gov registry record · Phase 2
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
A Phase 2 study of Amyloidosis and Transthyretin Amyloidosis, sponsored by Oregon Health and Science University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05758493: Recruiting Phase 2 study of Amyloidosis and Transthyretin Amyloidosis, sponsored by Oregon Health and Science University.
NCT05758493 is a Phase 2 study of Amyloidosis and Transthyretin Amyloidosis that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 150 participants, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05758493, a Phase 2 study of Amyloidosis and Transthyretin Amyloidosis, is actively recruiting participants, sponsored by Oregon Health and Science University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 124I-Evuzamitide
Study Locations (1)
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2028-03-10 |
| Phase | Phase 2 |
What NCT05758493 shows while recruiting
NCT05758493 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,123-participant average among 28 other Amyloidosis trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which 124I-Evuzamitide is the first listed.
NCT05758493 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT05758493 about?
NCT05758493 is a clinical study titled "Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis". 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 th...
What is the current status of trial NCT05758493?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-01-10. Estimated completion is 2028-03-10.
What conditions does trial NCT05758493 study?
This clinical trial studies the following conditions: Amyloidosis, Transthyretin Amyloidosis.
What interventions are being tested in trial NCT05758493?
The interventions under investigation include: 124I-Evuzamitide (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05758493?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05758493 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05758493's enrollment target sits among peer trials
150 13th of 28 higher than 16 of 28 other Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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