The purpose of this Phase 3, open label, single dose imaging study is to evaluate the efficacy and safety of I-124 evuzamitide (radioactive dye) for diagnosing Cardiac Amyloidosis in participants with suspected Cardiac Amyloidosis. The imaging test that will be used in this study is a Positron Emission Tomography Computed Tomography (PET/CT) scan.
This Phase 3, open label, single dose study will evaluate the efficacy and safety of I-124 evuzamitide when administered as a single dose prior to a PET/CT scan. Participants will be in the study for up to 60 days and approximately 200 participants with suspected Cardiac Amyloidosis will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
I-124 evuzamitide, single dose imaging agent, administered intravenously.
Mayo Clinic
Scottsdale, Arizona, United States
City of Hope - Duarte
Duarte, California, United States
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis-Sensitivity
Assessment of the sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Time frame: Up to 60 days after scanning
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis-Specificity
Assessment of specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Time frame: Up to 60 days after scanning
To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Treatment Emergent Adverse Events
Incidence of treatment-emergent Adverse Events (AEs) from Day 1 to Day 30.
Time frame: 30 days after administration of I-124 evuzamitide
To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Creatinine
Change in kidney function from baseline: Creatinine mg/dl
Time frame: 30 days after administration of I-124 evuzamitide
To evaluate the safety of a single intravenous administration of I-124 evuzamitide-eGFR
Change in kidney function from baseline: eGFR ml/min/1.73 m2
Time frame: 30 days after administration of I-124 evuzamitide
To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Liver function.
Change in liver function from baseline LDH units per liter; Alkaline phosphatase units per liter; SGOT units per liter; SGPT units per liter
Time frame: 30 days after administration of I-124 evuzamitide
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University of California
San Francisco, California, United States
Yale Cardiovascular Medicine
New Haven, Connecticut, United States
Cleveland Clinic
Weston, Florida, United States
Northwestern University
Chicago, Illinois, United States
Cook County Health
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Lukes (CVIT) Saint Luke's Health System
Kansas City, Missouri, United States
...and 10 more locations
To evaluate the safety of a single intravenous administration of I-124 evuzamitide.
Change in pregnancy test from baseline Pregnancy testing beta HCG serum testing negative or positive
Time frame: 30 days after administration of I-124 evuzamitide