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

Clinical Study of [18F]FT8 PET/CT in Evaluating Amyloidosis

This project tests whether a new PET tracer, 18F‑FT8, can safely and clearly image light‑chain (AL) cardiac amyloidosis in adults with suspected or known disease and in healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University (Academic / other)
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT07232459 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with suspected, newly diagnosed, or known cardiac amyloidosis supported by MRI, CT, serum biomarkers, or histopathology, as well as healthy volunteers who can attend the study imaging visits.

Not a fit: Patients whose cardiac amyloid is transthyretin (ATTR) rather than light‑chain (AL), or those unable to undergo PET/CT scanning, are unlikely to receive diagnostic benefit from this tracer.

Why it matters

Potential benefit: If successful, 18F‑FT8 PET could provide a more specific noninvasive way to visualize AL cardiac amyloid and help distinguish it from other amyloid types, improving diagnostic accuracy and treatment decisions.

How similar studies have performed: Preclinical tissue studies showed high affinity of 18F‑FT8 for AL amyloid and minimal binding to transthyretin, and while other amyloid‑targeting PET tracers have shown promise, human PET use of 18F‑FT8 is a novel application.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 1 other locations

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Haonan Yu

Conditions Amyloid; Cardiac Amyloidosis; Amyloidosis; Healthy Subjects; PET/CT; Cardiac amyloidosis; immunoglobulin light chain