PET Scan Test for Light Chain Amyloidosis Heart Deposits
Tests a PET imaging agent, FT8, to detect AL amyloid in adults and healthy volunteers.
Plain-language title generated from the registry record
Registry title: [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis
Key facts
- Where
- Hefei, Qingdao, and Tianjin, ChinaSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with suspected or known cardiac amyloidosis who are scheduled for a Pan-Amyloid PET/CT scan, and for healthy adult volunteers. It tests a new PET scan tracer, [18F]FT8.
- Age
- 18 years or older
- Sex
- All
- Disease stage
- Patients: suspected, newly diagnosed or previously diagnosed cardiac amyloidosis, supported by cardiac MRI, contrast-enhanced CT, blood markers (such as NT-proBNP, Troponin) or tissue testing. Healthy volunteers: no sign of active heart or body-wide disease.
Main reasons for not taking part
- Confirmed amyloidosis outside the heart, or other non-amyloid heart disease that could confuse the images (patients)
- Pregnancy or breastfeeding
- Any condition that, in the investigator's opinion, prevents full participation or follow-up
- Significant heart, liver, kidney or nerve disorder, past or present (healthy volunteers)
Read by machine on 9 November 2026.
Where in China
- The First Affiliated Hospital of University of Science and Technology of ChinaHefei, ChinaTaking people
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University
- Trial code
- NCT07232459
- Record updated
- 8 September 2026
- Original description
[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.Read full original descriptionShow less
Clinical Study of [18F]FT8 PET/CT in Evaluating Amyloidosis
[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.
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; Amyloidosis Patients:; 2.1 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.