[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Medical University
About this trial
\[18F\]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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject Recruitment Participants will be recruited from outpatients and/or inpatient populations of the Hematology Department at Tianjin Medical University General Hospital. The principal investigator and collaborating hematologists will ensure consistent application of diagnosis and enrollment criteria based on standardized guidelines. The planned enrollment includes 20 patients with systemic amyloidosis (including cardiac involvement) and 5 healthy volunteers.
Adult patients (age ≥ 18 years);
Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis.
Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation.
Disqualifiers
Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.
Pregnancy or breastfeeding.
Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up.
Adult subjects (age ≥ 18 years);
Trial population
Healthy volunteers and patients with confirmed or suspected systemic or cardiac amyloidosis, including cases secondary to hematologic disorders or genetic diseases.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
[18F]FT8
Diagnostic testEach subject will receive a single intravenous injection of \[18F\]FT8 and will undergo PET imaging at a specified time.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Healthy participants1 intervention
Group B: Amyloidosis Patients1 intervention
Trial outcomes
Primary outcomes
1
The 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-injection2
[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)Secondary outcomes
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)2
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)Sponsors and contacts
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Tianjin Medical University
Lead sponsor
Tianjin Medical University General Hospital
Collaborator
Source ClinicalTrials.gov