Actively Recruiting
Clinical Study of [18F]FT8 PET/CT Imaging to Evaluate Amyloidosis and Cardiac Involvement
Led by Tianjin Medical University · Updated on 2025-11-18
25
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University
Lead Sponsor
T
Tianjin Medical University General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of [18F]FT8, a diagnostic imaging agent, for detecting amyloidosis, including cardiac amyloidosis. This study aims to assess the safety and effectiveness of [18F]FT8 PET/CT scans in visualizing AL amyloid deposits in the heart, comparing its performance to established clinical methods such as echocardiography, MRI, and laboratory tests. The goal is to establish a reliable PET imaging protocol for direct diagnosis and differentiation of AL amyloidosis. Participants will receive a single intravenous injection of 10 b1 3 mCi of [18F]FT8, followed by a PET/CT scan to measure organ uptake using the standardized uptake value (SUV). The study includes both healthy volunteers and amyloidosis patients. The imaging and injection occur only once, and no additional treatments are administered. Clinical assessments and lab tests are done before and after the scan to monitor safety and gather diagnostic information. During the study, participants will undergo physical exams, cardiac function assessments, and tests of liver and kidney function before and after the PET/CT scan. Researchers will monitor safety from the time of injection up to seven days afterward, and evaluate organ uptake and biodistribution of [18F]FT8 at the time of the scan. Radiation exposure is also measured. Total participation involves a single visit for imaging and assessments, with follow-up safety monitoring over one week.
CONDITIONS
Brief Title
[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Suspected, newly diagnosed, or previously diagnosed cardiac amyloidosis confirmed by cardiac MRI, contrast-enhanced CT, serum biomarkers, or histopathology
- Scheduled for a Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation
- Able to understand the study procedures and provide written informed consent
- Healthy volunteers aged 18 years or older with no active cardiac or systemic disease confirmed by medical history, physical exam, and ECG
- Healthy volunteers able to understand the study procedures and provide written informed consent
You will not qualify if you...
- Confirmed non-cardiac amyloidosis or other non-amyloid cardiac diseases that may affect image interpretation
- Pregnancy or breastfeeding
- Any medical, psychological, or social condition that could impair participation or study completion
- History or current diagnosis of significant cardiac, hepatic, renal, or neurological disorders in healthy volunteers
- Any condition posing increased risk from study procedures or interfering with data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive a single intravenous injection of [18F]FT8 followed by a PET/CT scan to evaluate amyloidosis and cardiac involvement.
1 visit (in-person)
Duration - Up to 7 days post-injection
Participants are monitored for safety and undergo clinical assessments and laboratory tests including cardiac, hepatic, and renal function for up to 7 days after the injection.
Follow-up assessments during this period
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230000
Actively Recruiting
2
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 350005
Actively Recruiting
Research Team
H
Haonan Yu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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