[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis
Recruiting · NCT07232459 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tianjin Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
\[18F\]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.
Who can take part
Inclusion criteria
- Subjects must meet all of the following criteria:
- 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.
- Able to understand the study procedures and provide written informed consent. 2.2
Exclusion criteria
- Subjects will be excluded based on any of the following:
- 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.
- \. Healthy Volunteers: 3.1 Inclusion Criteria:
- Subjects must meet all of the following criteria:
- Adult subjects (age ≥ 18 years);
- No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).
- Able to understand the study procedures and provide written informed consent. 3.2 Exclusion Criteria:
- Subjects will be excluded based on any of the following:
- History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder.
- Pregnancy or breastfeeding.
- Any condition that, in the opinion of the investigator, could pose an increased risk from the study procedure or interfere with the interpretation of study data.
Where it is running
3 locations listed.
- The First Affiliated Hospital of University of Science and Technology of China - Hefei, Anhui, China
- The Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- Tianjin Medical University General Hospital - Tianjin, Tianjin Municipality, China