Clinical Study of [18F]FT8 PET/CT in Evaluating Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- The safety assessment
研究概览
简要总结
[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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Healthy participants
Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]FT8 followed by a PET/CT scan.
干预措施: [18F]FT8 (Diagnostic Test)
Amyloidosis Patients
Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]FT8, followed by a PET/CT scan.
干预措施: [18F]FT8 (Diagnostic Test)
结局指标
主要结局
The safety assessment
时间窗: From time of injection up to 7 days post-injection
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.
[18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV)
时间窗: At the time of the single [18F]FT8 PET/CT scan (Day 1)
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.
次要结局
- 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))
研究者
Shaobo Yao, PhD
Prof.
Tianjin Medical University