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临床试验/NCT01931488
NCT01931488Unknown2 期

The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG.

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
2 期
入组人数
40
试验地点
1
主要终点
Uptake of 123I-MIBG

研究概览

简要总结

The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine tumors. Comparison with 123I-MIBG.

详细描述

The autonomic nervous system consists of sympathetic and parasympathetic innervation.

The neurotransmitter of the sympathetic system is norepinephrine (NE) which in response to a stimulus, is released to the synaptic space Guanethidine is a false neurotransmitter analog of NE that is not catabolized . When labeled with radioactive iodine the radiotracer meta-iodobenzylguanidine (as I-MIBG) may be used for localization of different clinical and pathological conditions. There are two main indications for scintigrpahy with labeled MIBG 1. Whole body imaging of neuroendocrine tumors such as phechromocytoma and neuroblastoma. Scintigraphy allows staging of the disease as well as follow up in patients with MIBG-avid tumors. Moreover, when labeled with high doses of 131I it can be used for treatment in patients with metastatic neuroendocrine tumors. 2. the other indication of labeled MIBG scintigraphy is for assessment of myocardial sympathetic nerve endings Autonomic disturbances are of the common symptoms in Parkinson disease (PD). They may appear early in the disease occasionally prior to the motor symptoms, thus raising a potential use of autonomic system assessment as a biological marker for prediction of future development of motor PD.

Labeled MIBG imaging is a potential test for determining of the integrity of the individual autonomic function. Reduced MIBG uptake indicates postganglionic sympathetic dysfunction, which has been observed during the early stages of PD. MIBG scintigraphy is thought to be a sensitive modality for the diagnosis of PD, assisting in the differential diagnosis of other parkinsonian diseases, PD and other movement disorders. This method has also been reported to be of a high specificity.

The labeled MIBG used routinely is the tracer labeled with 123I which can be used with gamma camera for performance of planar imaging or 3D SPECT images. 123I emits predominantly γ photons with energies of 159 keV and has a half-life of 13.2 hour.

Quantitation of 123I MIBG myocardial uptake by the Heart to-Mediastinum ratio (H/M) measured from planar imaging has been found to be of predictive value for assessment of prognosis for cardiac events. H/M obtained from 123I MIBG SPECT was reported to improve the differentiation between subjects with normal and those with abnormal MIBG uptake.

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

  • Signed Informed Consent
  • Patients diagnosed with Parkinson disease
  • Patients with histologically confirmed neuroendocrine tumors

排除标准

  • Age < 18
  • Any cardiovascular disease
  • Taking medications that influence the sympathetic system

结局指标

主要结局

Uptake of 123I-MIBG

时间窗: day 1

At day 1 patients will be injected with 123I-MIBG 6 mci (222 MBq). 3 hours post-injection patients will undergo planar and SPECT imaging. Uptake of 123I-MIBG will be quantified as heart/mediastinum ratio measured from planar imaging.

次要结局

未报告次要终点

研究者

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

Michal Roll PhD,MBA

DIRECTOR

Tel-Aviv Sourasky Medical Center

研究点 (1)

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