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

Официальное название

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

Обзор

\[18F\]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.

Подробное описание

Subjects will undergo \[18F\]FT8 PET/CT scans for safety and diagnostic efficacy evaluation. Organ uptake will be quantified using the standard uptake value (SUV). Clinical assessments and laboratory tests, including baseline information collection, physical examination, cardiac function assessment, and hepatic and renal function tests, will be conducted before and after the scan.

Вмешательства

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

Первичные конечные точки

• The safety assessment [Срок оценки: From time of injection up to 7 days post-injection]
• [18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV) [Срок оценки: At the time of the single [18F]FT8 PET/CT scan (Day 1)]

Вторичные конечные точки (2)

• The Biodistribution of [18F]FT8 in subjects [Срок оценки: At the time of the single [18F]FT8 PET/CT scan (Day 1)]
• Radiation Dosimetry [Срок оценки: At the time of the single [18F]FT8 PET/CT scan (Day 1)]

Критерии участия

• 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.

3\. 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of University of Science and Technology of China — Хэфэй
• Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07232459 · TJMUGH-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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