Use of [18F]FET PET-MRI to improve detection of pituitary adenomas in Cushing’s disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary endpoint of this prospective evaluation is the difference in the proportion of patients with ACTH-dependent hypercortisolism in whom CD is correctly distinguished from ectopic CS using [18F]FET PET-MRI versus IPSS. [18F]FET PET-MRI will be compared for non-inferiority to the current standard IPSS.
研究概览
简要总结
The main objective is to compare the proportion of patients with ACTH-dependent hypercortisolism in whom Cushing's disease (CD) is correctly differentiated from ectopic Cushing's syndrome (CS) using [18F]FET PET-MRI compared to IPSS.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Age ≥18 years
- •Biochemically confirmed ACTH-dependent hypercortisolism, defined as: Non-suppressed ACTH levels plus minimal 2 of the following: Overnight 1mg dexamethasone suppression test > 50 nmol/L; and/or Elevated late night salivary cortisol (min. 2/3 measurements); and/or Elevated 24-hours urinary free cortisol (min. 2 measurements)
- •Pituitary microadenoma (< 10mm) OR negative / inconclusive findings on standard MRI of the pituitary sella-region.
- •Indication for further evaluation with IPSS.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Non-ACTH dependent hypercortisolism;
- •Pituitary macroadenoma (≥ 10mm);
- •Suspicion of Pseudo-Cushing’s disease (e.g. due to alcohol use disorder, PCO’s, obesity, depression) according to standard work up / guidelines;
- •Use of glucocorticosteroids;
- •Impaired renal function, defined as eGFR (MDRD) <30ml/min/1,73 m
- •An exception can be made in consultation with the treating physician;
- •Impaired Liver function;
- •Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered;
- •Known allergic reaction to therapeutic radiopharmaceuticals;
- •Inability to lie still in supine position for the duration of the PET-MRI scan;
- •Other conditions that make it impossible to perform a PET-MRI scan, such as neurological disease, severe immobility, or unsuppressable claustrophobia.
结局指标
主要结局
The primary endpoint of this prospective evaluation is the difference in the proportion of patients with ACTH-dependent hypercortisolism in whom CD is correctly distinguished from ectopic CS using [18F]FET PET-MRI versus IPSS. [18F]FET PET-MRI will be compared for non-inferiority to the current standard IPSS.
The primary endpoint of this prospective evaluation is the difference in the proportion of patients with ACTH-dependent hypercortisolism in whom CD is correctly distinguished from ectopic CS using [18F]FET PET-MRI versus IPSS. [18F]FET PET-MRI will be compared for non-inferiority to the current standard IPSS.
次要结局
- Secondary endpoints include the sensitivity, specificity, positive and negative predictive value of the two techniques for the exact localization of ACTH-secreting PitNETs, based on post-operative neurosurgery and pathology reports as well as biochemical remission as reference standards. The area under the curve (AUC) for both techniques will be calculated from the receiver operating curve (ROC).
研究者
drs. R. van der Groef
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)