跳至主要内容
临床试验/NCT06226987
NCT06226987招募中不适用

Molecular Imaging in Fabry Disease of the Heart

University of Cambridge1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
PET imaging vs. fibrosis detected by MRI

研究概览

简要总结

Better methods for early detection of cardiac involvement in Fabry disease are needed to inform clinical management decisions that can help prevent or slow the progression of cardiac complications. In the Molecular Imaging of Inflammation in Fabry Disease of the Heart study, the investigators will test the use of 68Ga-DOTATATE PET/MRI for identifying myocardial inflammation in patients with Fabry disease.

详细描述

Fabry disease (OMIM 30150) is caused by mutations in the gene (AGAL) encoding for the lysosomal enzyme α-galactosidase A. Diminished activity of this enzyme results in progressive accumulation of its substrate globotriaosylceramide (Gb3) in the lysosomes of various cell types, including vascular endothelial cells, cardiomyocytes, valvular fibrocytes, conduction cells. The involvement of the heart in Fabry disease results in rhythm disturbances, progressive hypertrophy and scarring of the left ventricle leading to diastolic and systolic dysfunction.

Conventional diagnostic methods such as electrocardiography, transthoracic echocardiography and even magnetic resonance imaging (MRI) are not sensitive enough to detect early damage to myocardial tissue in Fabry disease. Identifying subtle early changes, at a point when specific treatment may be optimized, is therefore an area of ongoing interest. Early perspectives on Fabry heart involvement concentrated on the left ventricular hypertrophy. Later the widespread use of Cardiac MRI introduced the role of fibrosis, as suggested by the appearance of late gadolinium enhancement (LGE) in characteristic areas of the myocardium. Most recently, detection of oedema by T2-weighted imaging and/or T2-mapping on MRI, as well as 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning have pointed to the possibility of focal inflammation as a causative factor in progression of the myocardial disease to replacement fibrosis, with its attendant risk of fatal arrhythmia and cardiac decompensation. Whether the oedema signal on MRI sequences truly represents tissue inflammation in Fabry disease and whether LGE fully corresponds to replacement fibrosis remains unknown. Circulating markers of inflammation and immune activation are elevated in Fabry cardiomyopathy, but no fully specific marker has yet been found to correspond to either myocardial focal oedema or LGE.

Although MRI is important for diagnosis and risk stratification in patients with cardiac involvement in Fabry disease, findings such as LGE, myocardial oedema and native T1 mapping tell the clinician little that is specific about the underlying disease mechanisms. Moreover, early inflammatory changes may occur in Fabry disease before the manifestation of such abnormalities are detectable by MRI. By combining PET imaging of myocardial inflammation with detailed MRI assessments of cardiac function, structure and tissue characterisation, hybrid PET/MRI has the potential to offer a comprehensive non-invasive workup for patients with Fabry disease.

Previous work has shown that 68Ga-DOTA-(Tyr3)-octreotate (DOTATATE), a somatostatin receptor PET tracer used in oncology imaging, can be re-purposed to image inflammation in the cardiovascular system. This method could be of particular use in conditions associated with focal myocardial inflammation such as Fabry disease because of low physiological expression of somatostatin receptors in healthy heart muscle, and therefore low background PET signal. Here, the investigators will investigate the use of 68Ga-DOTATATE PET/MRI for identifying myocardial inflammation in patients with Fabry disease.

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

入选标准

  • Male or female participants >18 years old
  • Able to give written, informed consent and to lie flat
  • Have Fabry disease based on molecular diagnosis (at a minimum, documented enzyme deficiency in males and documented pathogenic mutation in females)
  • Cardiac MRI within 3 years documenting cardiac involvement in Fabry disease (left ventricular hypertrophy and/or late gadolinium enhancement and/or myocardial oedema)

排除标准

  • Any other diagnosis associated with cardiac muscle inflammation, including myocarditis
  • Previous gene therapy
  • Contra-indication to MRI scanning or intravenous gadolinium contrast (prior contrast reaction or chronic kidney disease with eGFR <30 mL/min/1.73 m2)
  • Women of child bearing potential not using adequate contraception
  • Uncontrolled atrial fibrillation
  • Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study

结局指标

主要结局

PET imaging vs. fibrosis detected by MRI

时间窗: Baseline

Concordance between 68Ga-DOTATATE PET signal and myocardial fibrosis detected by late gadolinium enhancement MRI

PET imaging vs. oedema detected by MRI

时间窗: Baseline

Concordance between 68Ga-DOTATATE PET signal and myocardial oedema on MRI assessed by T2-weighted imaging

次要结局

未报告次要终点

研究者

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

Jason Tarkin

Wellcome Clinical Research Career Development Fellow & Honorary Consultant Cardiologist

University of Cambridge

研究点 (1)

Loading locations...

相似试验