A Pilot Study to Evaluate 18F Florbetapir Binding to Cardiac Amyloid in Patients Undergoing Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
研究概览
简要总结
This is a pilot study designed to assess for relative change in cardiac 18F Florbetapir uptake in patients with AL cardiac amyloidosis after appropriate chemotherapy.
详细描述
Current research involving [18F]-florbetapir in relationship to cardiac amyloid has taken advantage of the ability of the radiopharmaceutical to bind specifically to amyloid fibrils. It has previously been established that the degree of radiotracer uptake correlates with the density of Beta-amyloid plaque. The ability to quantify this uptake makes [18F]-florbetapir imaging a potential tool to evaluate cardiac response in patients undergoing therapy for AL amyloidosis. It would provide a much-needed tool to monitor cardiac response to chemotherapy to potentially adjust chemotherapy if response was not adequate. It could also provide a tool by which investigators would be able to evaluate new therapies designed to decrease the burden of formed amyloid fibrils within the heart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged > 18 years are eligible.
- •Patient must provide informed consent to participate in the study protocol.
- •All patients must have clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or cardiac MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis).
- •Planned plasma cell-directed chemotherapy.
- •A negative pregnancy test will be required for all women of child bearing potential, breast feeding is not permitted.
- •Patients must be able to undergo PET-CT imaging
- •Patients must be able to complete 6-minute walk test
排除标准
- •Severe claustrophobia
- •Allergy to F-18 florbetapir
研究组 & 干预措施
Patients with AL cardiac amyloid
Patients enrolled will be patients > 18 years of age with a clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis) with plans to undergo plasma cell directed chemotherapy.
干预措施: F18 Florbetapir (amyvid) cardiac PET/CT imaging (Drug)
结局指标
主要结局
Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
时间窗: six months
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
Relative Change in Cardiac Uptake of 18F Florbetapir Prior to Chemotherapy and After Six Months of Chemotherapy.
时间窗: six months
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
次要结局
- six minute walk test(twelve months)
- Hematologic response(12 months)
- Cardiac response(12 months)
- Patient related outcomes(12 months)
- Six Minute Walk Test(twelve months)
- Hematologic Response(12 months)
- Cardiac Response(12 months)
- Patient Related Outcomes(12 months)
研究者
Christopher Mueller
MD, Assistant Professor Department of Medicine.
Medical College of Wisconsin