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Cardiac Amyloidosis / Amyloid / [18F]FT8 · Observational Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered observational study of a novel PET tracer ([18F]FT8) designed to detect immunoglobulin light chain cardiac amyloidosis. No outcome data are posted; the registry record describes only the planned protocol and primary measures (safety and organ uptake by SUV).
Observational. Amyloid, Cardiac Amyloidosis, Amyloidosis, Healthy Subjects; age from 18 Years; accepts healthy volunteers. Intervention: Healthy participants; Amyloidosis Patients. Compared with: Clinical methods including echocardiography, contrast-enhanced MRI, and laboratory tests (role and conduct not detailed in registry record). n = 25. 3 sites: China.
This is a registered observational study of a novel PET tracer ([18F]FT8) designed to detect immunoglobulin light chain cardiac amyloidosis. No outcome data are posted; the registry record describes only the planned protocol and primary measures (safety and organ uptake by SUV).
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Once results are posted, this study may establish whether [18F]FT8 PET can safely and reliably differentiate AL amyloidosis from other amyloid types and support clinical diagnosis. Clinicians should not interpret this registry record as confirming efficacy; results are not yet available.
This is an ongoing observational diagnostic imaging study with no posted results; it is designed to evaluate safety and diagnostic performance of a novel PET tracer in a small, planned cohort.
As stated by the source record.
Quoted from the source exactly as published.
Once results are posted, this study may establish whether [18F]FT8 PET can safely and reliably differentiate AL amyloidosis from other amyloid types and support clinical diagnosis. Clinicians should not interpret this registry record as confirming efficacy; results are not yet available.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07232459). This is a study registration, not published results. Lead sponsor: Tianjin Medical University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 25 participants (ESTIMATED). Conditions: Amyloid, Cardiac Amyloidosis, Amyloidosis, Healthy Subjects. Interventions: DIAGNOSTIC_TEST: [18F]FT8. Primary outcome measures: The safety assessment , From time of injection up to 7 days post-injection; [18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV) , At the time of the single [18F]FT8 PET/CT scan (Day 1). Brief summary: \[18F\]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene (\[18F\]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish \[18F\]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of \[18F\]FT8 PET imaging in human subjects.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.