\[18F\]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.
Subjects will undergo \[18F\]FT8 PET/CT scans for safety and diagnostic efficacy evaluation. Organ uptake will be quantified using the standard uptake value (SUV). Clinical assessments and laboratory tests, including baseline information collection, physical examination, cardiac function assessment, and hepatic and renal function tests, will be conducted before and after the scan.
Study Type
OBSERVATIONAL
Enrollment
25
Each subject will receive a single intravenous injection of \[18F\]FT8 and will undergo PET imaging at a specified time.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe safety assessment
The incidence of adverse events assessed by the investigator as related to the \[18F\]FT8 injection. Systematically collect and assess all adverse events within 7 days post-injection through physical examinations, vital signs monitoring, clinical laboratory tests (complete blood count, hepatic and renal function). All events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time frame: From time of injection up to 7 days post-injection
[18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV)
Quantification of \[18F\]FT8 uptake in major organs (e.g., heart, liver, kidneys) using the Standardized Uptake Value (SUV). This measurement will be performed on the PET/CT scans acquired at a specified time. The outcome will be reported as the SUV for each organ in both amyloidosis patients and control subjects.
Time frame: At the time of the single [18F]FT8 PET/CT scan (Day 1)
The Biodistribution of [18F]FT8 in subjects
Semi-quantitatively evaluate the tracer's uptake in the interest organs (including heart, liver, kidneys, lungs, brain, bones, thyroid, blood pool, and other related organs) by measuring the Standard Uptake Value (SUV).
Time frame: At the time of the single [18F]FT8 PET/CT scan (Day 1)
Radiation Dosimetry
Calculate the effective radiation dose (mSv) to various human organs and the whole body.
Time frame: At the time of the single [18F]FT8 PET/CT scan (Day 1)
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