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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoint revised
    • Secondary endpoints: 5 to 7
    • Collaborators: 1 to 2
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Enrollment target: 30 to 150
    • Primary completion date: Apr 10, 2024 to Dec 10, 2027
    • Study completion date: Jul 10, 2024 to Mar 10, 2028
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05758493
Lead Sponsor Oregon Health and Science University
Collaborators: Attralus, Inc., Bayer
Conditions
(from sponsor)		 Amyloidosis, Transthyretin Amyloidosis
Related terms Amyloidosis, Amyloidosis, Hereditary, Transthyretin-Related
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov