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临床试验/NCT03347760
NCT03347760已完成不适用

Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2020年7月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation

研究概览

简要总结

Infectious myocarditis are frequent, most of the time viral and can evolve to cardiac insufficiency. The diagnosis is difficult because they can mime an acute coronary syndrome. Approximately 10 % of patients with acute infarction suspected, have a normal angiography, and half of them has in fact a myocarditis, as showed studies of cardiac MRI among which some realized in our department . However, anomalies observed in MRI are not specific and it is necessary to use multiple criterions. A new radiopharmaceutical, the 68Ga-DOTATOC, specific of somatostatin's receptors which are over expressed by the inflammatory cells, has recently showed the capacity to identify myocarditis, but only in a small group of 6 patients.

The investigators make assumptions:

  1. this radiopharmaceutical is enough sensitive to detect most of the acute inflammatory myocarditis which are identified by the MRI and
  2. it could maybe allow to identify myocarditis with a persistent subacute or chronic inflammation, which are difficult to identify with cardiac MRI, and it would be a new information able to guide the medical decision.

Primary objectif: to determine if PET with 68Ga-DOTATOC is enough sensitive to identify myocarditis in acute inflammatory phase by hospitalized patients with suspected acute infarction and with normal angiography and who have a high probability of myocarditis identified by MRI. Disease prevalence will be close to 100 % at baseline Secondary objectives: 1. Estimate the frequency of inflammatory forms (subacute or chronicle), with a 68Ga-DOTATOC PET at 3 to 5 months from baseline, when classic signs of acute inflammatory generally disappeared (CRP, Troponin-I, myocardial oedema in MRI).

2. Analyze the concordance of the results of 68Ga-DOTATOC TEP by two readers

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

入选标准

  • Adult subjects who have given their written consent to participate in the study.
  • Patients without history of heart disease, hospitalized for acute infarction suspected with positive troponine, normal or subnormal angiography and which have a high probability of acute inflammatory myocardities on the secondarily realized MRI (= 2 criteria of Lake Louise)
  • No contraindication to perform a 68Ga-DOTATOC-PET .
  • Patient belong to a social security scheme.

排除标准

  • Patients under guardianship or curatorship.
  • Pregnancy, breastfeeding and woman of childbearing age without effective contraception
  • Impossibility to perform a PET with 68Ga-DOTATOC (patient agitated).
  • Impossibility to schedule PET/CT before the deadline = in 7 days since the beginning of the hospitalization.

研究组 & 干预措施

Experimental arm

Experimental

All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later

干预措施: blood sample (Biological)

Experimental arm

Experimental

All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later

干预措施: DOTATOC-68Ga PET at 6 months (Drug)

Experimental arm

Experimental

All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later

干预措施: DOTATOC-68Ga PET initial (Drug)

结局指标

主要结局

Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation

时间窗: at baseline

The criterion of positivity will be that of a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study.

次要结局

  • Frequency of a significant myocardial retention of 68Ga-DOTATOC during initial staging(6 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elodie CHEVALIER

Dr

Central Hospital, Nancy, France

研究点 (2)

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