Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Metomidate Imaging for Adrenal Neoplasia (FAMIAN-Study) - a Diagnostic Study - FAMIAN-Study

niversity Hospital Wuerzburg0 个研究点目标入组 220 人开始时间: 2015年6月10日最近更新: 2015年10月6日

适应症

试验速览

暂无简介。

•Patients with a solid indeterminate adrenal mass scheduled for surgery (within 3 months) and a diameter > 3 cm or an increase in tumor diameter of > 1 cm in follow-up imaging. In unenhanced computerized tomography (CT) the attenuation value of the adrenal tumor is = 10 Hounsfield units (HU).
•Age = 30 years.
•Written informed consent.
•ECOG performance status 0-2
•Effective contraception in pre-menopausal female patients
•Negative pregnancy test
•Patient´s signed written informed consent
•Ability to comply with the protocol procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•Pregnancy or breast feeding
•Patient unfit or unwilling to undergo surgery
•Biochemical evidence of pheochromocytoma
•Diagnosis of primary hyperaldosteronism
•Overt adrenal Cushing’s syndrome or morning serum cortisol after dexamethasone (1 mg at 23.00 h) > 5 µg/dl (140 nmol/l) AND urinary free cortisol levels twice the upper limit of normal

发起方

niversity Hospital Wuerzburg