Use of [18F]FET PET-MRI to Improve Detection of Pituitary Adenomas in Cushing's Disease - a Prospective Diagnostic Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Comparison of the proportion of correct distinctions between CD and ectopic CS in patients with ACTH-dependent hypercortisolism using [18F]FET PET-MRI versus IPSS
研究概览
简要总结
In ACTH-dependent hypercortisolism it is important to distinguish between Cushing's disease (CD), with ACTH production by a pituitary neuroendocrine tumour (PitNET) and Cushing's syndrome (CS), with ectopic ACTH production. Bilateral inferior petrosal sinus sampling (IPSS) is the gold standard for this distinction, with a diagnostic accuracy of 98%. However, IPSS is an invasive procedure and an indi-rect diagnostic method, rarely providing reliable data on the exact location of the PitNET. This has a major impact on the therapeutic approach, short and long-term remission rates, and other outcomes. Hybrid Positron-emission tomography-Magnetic Resonance Imaging (PET-MRI) using O-(2-[18F]-fluo-roethyl)-L-tyrosine ([18F]FET) is promising in this respect. Recent data published by our research group demonstrate a a sensitivity of 100% a high accuracy in in the precise localization of ACTH-secreting PitNETs. We hypothesize that [18F]FET PET-MRI could become the new non-invasive diagnostic stand-ard, but data regarding a direct comparison between the diagnostic impact of [18F]FET PET-MRI versus IPSS in the differentiation between CD and ectopic CS are lacking. In addition, there are currently no other reliable biomarkers to distinguish the two disorders. The investigators hypothesize that the ACTH-dependent biomarker copeptin could be a valuable addition in this regard. The aim of this prospective diagnostic study is to compare the diagnostic accuracy of [18F]FET-PET-MRI and IPSS in differentiating CD from ectopic CS in patients with ACTH-dependent hypercortisolism.
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
- 否
入选标准
- •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
- •Elevated late night salivary cortisol (min. 2/3 measurements)
- •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
- •Non-ACTH dependent hypercortisolism
- •Pituitary macroadenoma (≥ 10mm)
- •Suspicion of Pseudo-Cushing's disease (e.g. due to alcohol use disorder, PCO's, obesity, de-pression) 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.
研究组 & 干预措施
[18F]FET-PET-MRI vs IPSS for diagnosing CD vs ectopic CS in ACTH-dependent cases
Participants will undergo both [18F]FET-PET-MRI and inferior petrosal sinus sampling (IPSS) to evaluate their diagnostic performance in differentiating Cushing's disease from ectopic ACTH secretion. Results of both procedures will be made available to the treating medical team and participants as they become available.
干预措施: [18F]FET PET-MRI (Diagnostic Test)
结局指标
主要结局
Comparison of the proportion of correct distinctions between CD and ectopic CS in patients with ACTH-dependent hypercortisolism using [18F]FET PET-MRI versus IPSS
时间窗: Patients will receive standard surgical or radiotherapeutic treatment. The study will collect follow-up data 3-6 months post-treatment without influencing clinical management or requiring study-specific visits.
The difference in the proportion of correct distinction between CD and ectopic CS in patients with ACTH-dependent hypercortisolism using \[18F\]FET PET-MRI versus IPSS
次要结局
- Copeptin values during IPSS(During the IPSS)
- ACTH values during IPSS(During the IPSS)
- Comparison of the diagnostic accuracy between [18F]FET PET-MRI and IPSS for differentiating between CD and ectopic CS in patients with ACTH-dependent hy-percortisolism(Follow-up data 3-6 months post-treatment)
- Exact localization of small functional PitNETs in patients with CD using the [18F]FET PET-MRI(perioperative)
- Exact localization of small functional PitNETs in patients with CD using the inferior petrosal sinus sampling (IPSS)(perioperative)
- Exact localization of small functional PitNETs in patients with CD using the structural MRI(perioperative)