Heart failure & cardiomyopathies
Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14)): A Phase 1/2 Study
Authors' conclusion
124I-evuzamitide is an amyloid-binding radiotracer capable of detecting cardiac amyloid in patients with high sensitivity.
Study context
- Population
- Patients with diverse types of systemic amyloidosis, asymptomatic transthyretin variant carriers and healthy volunteers
- Participants
- 50 / 2 / 5
- Comparison
- Systemic amyloidosis vs Asymptomatic transthyretin sequence variant carriers vs Healthy volunteers
- Systemic amyloidosisn = 50
- Asymptomatic transthyretin sequence variant carriersn = 2
- Healthy volunteersn = 5
- Outcome
- Safety, biodistribution and sensitivity of a single IV infusion of 124I-evuzamitide (PET/CT)
Methodological detailssingle-site, open label, 1.4 ± 0.2 mg of 124I-evuzamitide (71.5 ± 12.4 MBq); PET/CT at 5.2 hours (Q25-Q75: 4.9-5.4 hours) postinfusion
- Single-site
- Open label
- 1.4 ± 0.2 mg of 124I-evuzamitide (71.5 ± 12.4 MBq); PET/CT at 5.2 hours (Q25-Q75: 4.9-5.4 hours) postinfusion
Main finding
As reported in the abstract
Sensitivity of 124I-evuzamitide PET/CT (imaging vs clinical observations)
Patient-associated sensitivity
93.6%
95% CI 82.8%–97.8%
Cardiac-associated sensitivity
96.2%
95% CI 81.8%–99.8%
Further findings
Semi-quantitative uptake vs serum NT-proBNP (light chain-associated amyloidosis)
- Uptake correlated significantly with serum NT-proBNP
Cardiac uptake in healthy volunteers
- Cardiac uptake not observed in any healthy volunteers
- 0
Adverse events and deaths
- Drug-related adverse events
- 1
- Deaths
- 0
- Well tolerated
Original publication
Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14)): A Phase 1/2 Study. JACC Cardiovasc Imaging. doi:10.
Summarised from the published abstract; every number is checked against it