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临床试验/NCT01567111
NCT01567111已完成不适用

Functional Imaging With 11C-Metomidate Positron Emission Tomography Versus Adrenal Vein Sampling in Differential Diagnosis of Unilateral and Bilateral Aldosterone Secretion in Primary Aldosteronism

Helsinki University Central Hospital3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)

研究概览

简要总结

Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of secondary hypertension. The diagnosis and targeted treatment of PA is essential because of high vascular morbidity associated with PA as compared to essential hypertension with comparable blood pressure levels. PA is usually caused by either a unilateral aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction between APA and BAH is critical since the former may be cured by adrenalectomy, and the latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA). Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s) producing the most of aldosterone excess. The distinction between unilateral and bilateral PA can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning which does not distinguish between aldosterone-producing and common non-functioning adrenal nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive, dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).

Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy, use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1 and 5 years.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biochemically proven PA
  • Good general health enabling possible adrenalectomy
  • BMI less than 35

排除标准

  • Any contraindication for AVS, MTO-PET or CT
  • Subjects not willing to consider adrenal surgery
  • Pregnancy
  • Familial PA
  • Suspicion of other tumor than adenoma or hyperplasia in adrenal CT scan

研究组 & 干预措施

Subjects with PA

Experimental

All study subjects have biochemically confirmed PA and undergo adrenal CT, AVS and MTO-PET to diagnose lateralization of aldosterone production.

干预措施: 11C-Metomidate Positron Emission Tomography (Procedure)

结局指标

主要结局

Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)

时间窗: Up to 12 weeks

Mean and maximun SUV-values detect lateralization / no lateralization in aldosterone production in MTO-PET as compared to AVS.

次要结局

  • Blood pressure response(1 and 5 years)
  • Standard uptake value (SUV) in 11C metomidate Positron emission tomography (MTO-PET)(Up to 12 weeks)

研究者

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

Niina Matikainen

M.D., Ph.D., Specialist in endocrinology

Helsinki University Central Hospital

研究点 (3)

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