Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Attralus, Inc. | INDUSTRY |
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ATTR-CM | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 124I-Evuzamitide | Diagnostic Test | Amyloid reactive protein used as imaging agent to detect systemic amyloidosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| I-124 evuzamitide diagnostic accuracy | 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:
| At baseline scan |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative measures | To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on quantitative scan interpretation, compared to SoC site diagnosis. We will assess the sensitivity and specificity of various quantitative measures, and evaluate inter- and intra-reader agreement. | At baseline scan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Masri, MD | Contact | 503-418-1964 | masria@ohsu.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34786667 | Background | Wall JS, Martin EB, Endsley A, Stuckey AC, Williams AD, Powell D, Whittle B, Hall S, Lambeth TR, Julian RR, Stabin M, Lands RH, Kennel SJ. First in Human Evaluation and Dosimetry Calculations for Peptide 124I-p5+14-a Novel Radiotracer for the Detection of Systemic Amyloidosis Using PET/CT Imaging. Mol Imaging Biol. 2022 Jun;24(3):479-488. doi: 10.1007/s11307-021-01681-2. Epub 2021 Nov 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| C567782 | Amyloidosis, Hereditary, Transthyretin-Related |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake |
Pearson Correlation Coefficient of stage of amyloidosis (Mayo Staging System) and SUV (124I-Evuzamitide) |
| At baseline scan |
| Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide | During baseline scan and follow up scan |
| Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake | During baseline scan and follow up scan |
| Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake | During baseline scan and follow up scan |
| Proportion of patients with ATTR-CM and MGUS or smoldering myeloma who are correctly classified as ATTR-CM based on 124I-Evuzamitide distribution and uptake | During baseline scan |
| To evaluate the safety of a single intravenous administration of I-124 evuzamitide. | Incidence of related treatment-emergent (S)AEs from time of study drug administration to Day 7 | 7 days from baseline scan |