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临床试验/NCT01683825
NCT01683825已完成4 期

Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
23
试验地点
1
主要终点
Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean

研究概览

简要总结

The primary aim of this pilot study is to determine whether amyloid deposits in the heart can be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll 15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a control group.

The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind to the myocardial amyloid deposits and help quantify cardiac amyloid burden.

A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of the myocardium.

详细描述

F-18 florbetapir has been studied in multiple clinical trials to image beta-amyloid deposition in the brain of subjects with Alzheimers' disease. Florbetapir F-18 has been well tolerated in studies of more than 2000 human subjects. Biodistribution studies in humans revealed predominantly hepatobiliary excretion. The tracer clears rapidly from the blood pool in about 20 minutes. This radiotracer has been recently approved for clinical imaging of brain amyloid in subjects with suspected Alzheimers disease. The investigators propose to test this FDA approved radiotracer for an off label indication in a pilot study to evaluate its potential utility, if any, to image cardiac amyloidosis.

Amyloid related heart disease is associated with LV wall thickening due to infiltration; however, this myocardial wall thickening is not definitively distinguishable from left ventricular myocyte hypertrophy from increased afterload to the heart from hypertension or aortic stenosis. Typically myocardial or other tissue biopsy with typical echo features of amyloidosis is required for confirmation of amyloidosis. This pilot study is designed to understand whether cardiac amyloid burden can be measured using a specific radiotracer targeted against amyloid protein (F-18 Florbetapir). At this point it is unknown of F-18 Florbetapir will bind to either AL or TTR amyloid protein or to both of them or to neither of them. The investigators would like to study 15 patients with AL and 15 patients with TTR amyloidosis to understand these differences if any. The investigators also seek to understand if the signal to noise ratio of the circulating amyloid protein in the blood pool (AL amyloid disease) allows for good differentiation of myocardial amyloid uptake. 15 individuals without cardiac amyloidosis will also be enrolled as controls for this study.

The purpose of the proposed research study is to examine in detail, using quantitative PET, myocardial F-18 Florbetapir uptake in cardiac amyloidosis in order to better understand mechanisms of heart damage in this disease. A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of the myocardium in a subset of patients with amyloidosis who return for a second F-18 florbetapir scan within 30 days.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Inclusion criteria for amyloid subjects:
  • Age > 18 years
  • Biopsy proven amyloidosis outside the heart with typical echocardiographic appearance of cardiac involvement, or a positive cardiac biopsy.
  • Diagnosis of AL amyloidosis by standard criteria (evidence of plasma cell dyscrasia with appropriate tissue staining for AL) OR
  • Diagnosis of TTR amyloidosis (no evidence of plasma call dyscrasia and positive TTR staining of amyloid in tissue biopsy)
  • Able and willing to provide informed consent to participate in the study procedures

排除标准

  • Pregnancy
  • Serious non-cardiac medical illness which will preclude research study participation

研究组 & 干预措施

F-18 florbetapir PET-Amyloid Subjects

Experimental

Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).

干预措施: F-18 florbetapir PET (Drug)

F-18 florbetapir PET-Healthy Controls

Other

Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).

干预措施: F-18 florbetapir PET (Drug)

F-18 florbetapir PET-Amyloid Reproducibility Subjects

Experimental

Some of the individuals with documented cardiac amyloidosis from arm 1 will undergo a second F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) within 30 days to measure reproducibility

干预措施: F-18 florbetapir PET (Drug)

结局指标

主要结局

Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean

时间窗: 1 day

Standardized uptake value (SUV) mean is defined as the mean F-18 florbetapir activity concentration \[kBq/ml\] measured within the left ventricular myocardial region of interest multiplied by the decay-corrected amount of injected F-18 florbetapir \[kBq\] normalized to patient weight \[g\]. In this study we will measure mean left ventricular global myocardial F-18 Florbetapir SUVmean on static images between 4 minutes to 30 minutes post injection of F-18 florbetapir.

次要结局

  • Percent Change in Global Left Ventricular F-18 Florbetapir SUVmean From Scan 1 to Scan 2(Repeat scan was performed a median of 7 days after baseline study (range 1-46 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharmila Dorbala

Director of Nuclear Cardiology

Brigham and Women's Hospital

研究点 (1)

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