[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis

NCT07232459 | Recruiting

• 1 other identifier: TJMUGH-12
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

\[18F\]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.

Conditions

Amyloid; Cardiac Amyloidosis; Amyloidosis; Healthy Subjects

Keywords

PET/CT; Cardiac amyloidosis; immunoglobulin light chain

Outcome Measures

Primary Outcomes (2)

• The safety assessment

  The incidence of adverse events assessed by the investigator as related to the \[18F\]FT8 injection. Systematically collect and assess all adverse events within 7 days post-injection through physical examinations, vital signs monitoring, clinical laboratory tests (complete blood count, hepatic and renal function). All events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

  From time of injection up to 7 days post-injection

• [18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV)

  Quantification of \[18F\]FT8 uptake in major organs (e.g., heart, liver, kidneys) using the Standardized Uptake Value (SUV). This measurement will be performed on the PET/CT scans acquired at a specified time. The outcome will be reported as the SUV for each organ in both amyloidosis patients and control subjects.

  At the time of the single [18F]FT8 PET/CT scan (Day 1)

Secondary Outcomes (2)

• The Biodistribution of [18F]FT8 in subjects

  At the time of the single [18F]FT8 PET/CT scan (Day 1)

• Radiation Dosimetry

  At the time of the single [18F]FT8 PET/CT scan (Day 1)

Study Arms (2)

Healthy participants

Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]FT8 followed by a PET/CT scan.

Diagnostic Test: [18F]FT8

Amyloidosis Patients

Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]FT8, followed by a PET/CT scan.

Diagnostic Test: [18F]FT8

Interventions

[18F]FT8 DIAGNOSTIC_TEST

Each subject will receive a single intravenous injection of \[18F\]FT8 and will undergo PET imaging at a specified time.

Amyloidosis Patients; Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with confirmed or suspected systemic or cardiac amyloidosis, including cases secondary to hematologic disorders or genetic diseases.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Tianjin Medical University: lead
• Tianjin Medical University General Hospital: collaborator

Study Sites (2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 350005, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Amyloid Neuropathies, Familial; Amyloidosis

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Heredodegenerative Disorders, Nervous System; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies

Central Study Contacts

Haonan Yu

CONTACT

+8613821000597; dreamadam@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 18, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)