18F‑FT8 PET imaging for light‑chain (AL) cardiac amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will perform 18F‑FT8 PET/CT scans in up to 20 patients with systemic amyloidosis (including cardiac involvement) and 5 healthy volunteers to evaluate safety and diagnostic performance. Organ uptake will be quantified by standard uptake value (SUV) and compared to established clinical methods such as echocardiography, contrast‑enhanced cardiac MRI, and relevant laboratory biomarkers. Clinical assessments, baseline history, physical exam, and hepatic and renal function tests will be done before and after imaging to monitor safety. The primary goal is to define a robust PET protocol for direct visualization and differential diagnosis of AL amyloidosis in the heart.

Why it matters

Who can join: the full rules

1. 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.
2. Amyloidosis Patients:

2.1 Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Adult patients (age ≥ 18 years);
2. 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.
3. Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation.
4. 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:

1. Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.
2. Pregnancy or breastfeeding.
3. 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.

3\. Healthy Volunteers: 3.1 Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Adult subjects (age ≥ 18 years);
2. No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).
3. 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:

1. History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder.
2. Pregnancy or breastfeeding.
3. 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's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• The Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Recruiting
• Tianjin Medical University General Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Haonan Yu
• Email: dreamadam@126.com
• Phone: +8613821000597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.