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临床试验/NCT00454103
NCT00454103已完成1 期

Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

University of Wuerzburg1 个研究点 分布在 1 个国家开始时间: 2007年3月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
试验地点
1

研究概览

简要总结

The improvement of conventional imaging techniques has led to an increased detection rate of different adrenal tumors. Since those tumors can belong to a variety of entities the therapeutic consequences also show considerable variation. In order to definitely determine the type of tumor, invasive procedures like CT guided biopsies are often required, which could be avoided by a tumor specific imaging method. The presently available scintigraphic procedures are either time consuming and lead to high radiation exposure or are technically demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adrenal tumor seen by CT or MRT-scan with diameter of at least 2 cm or patient with adrenocortical carcinoma and suspected metastasis or local recurrence or patients with primary hyperaldosteronismus and adrenal tumour > 1 cm
  • Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria
  • Age ≥ 30 Jahre
  • Effective contraception (pearl index <1%)
  • Written informed consent

排除标准

  • Pregnancy or breast feeding
  • Renal insufficiency (serum creatinine > 2,0 mg/dl or MDRD < 60 ml/min)
  • Known allergy to etomidate or constituents of the test drug

研究者

发起方
University of Wuerzburg
申办方类型
Other

研究点 (1)

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