Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- [18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas
研究概览
简要总结
Cushing's disease results from adrenocorticotropic hormone (ACTH) secretion by corticotroph pituitary neuroendocrine tumors (PitNETs). Magnetic resonance imaging (MRI) is the reference modality for etiological diagnosis but may to visualize small corticotroph microadenomas in up to 30% of the cases, and false positives may occur.
The study hypothesis is that positron emission tomography (PET) using [18F]fluoroethyl-L-tyrosine ([18F]FET) improves localization of ACTH-secreting corticotroph microadenomas compared with MRI and could inform surgical planning and reduce reliance on invasive inferior petrosal sinus sampling.
This observational cohort (retrospective and prospective data) will assess the diagnostic performance of [18F]FET PET for tumor localization using postoperative histopathology as the gold standard.
Secondary aims include:
- assessing cases in which PET modifies localization relative to MRI and is correct by gold standard;
- inter-reader agreement between two nuclear medicine physicians;
- correlations between PET signal and biochemical markers of hypercortisolism
- uni- and multivariable analyses of clinical and imaging parameters influencing PET results;
- association between PET findings and subsequent biological remission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adults (≥18 years).
- •Biochemical diagnosis of Cushing's disease as part of initial management.
- •Pituitary MRI performed; if visible, microadenoma <10 mm in diameter.
- •Indication for discussion in multidisciplinary tumor board for surgical management.
排除标准
- •Minor (age <18 years).
- •Macroadenoma of the pituitary.
- •ACTH-dependent hypercortisolism secondary to ectopic secretion.
研究组 & 干预措施
Adults with Cushing's disease evaluated for pituitary surgery
Adults (≥18 years) with biochemically confirmed Cushing's disease with negative or doubtlful or microadenoma on pituitary MRI and are discussed for surgical management; who benefited from a[18F]FET PET in their clinical work-up.
干预措施: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers (Other)
结局指标
主要结局
[18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas
时间窗: 3 months
Proportion (%) of correct localization of the adenoma by \[18F\]FET PET, using postoperative histopathological examination of the surgical specimen as the reference standard.
次要结局
- Effect of PET on Tumor Localization Versus MRI(3 months)
- Inter-Reader Agreement of [18F]FET PET Interpretation(1 month)
- Correlation Between PET SUV and Hypercortisolism Biomarkers(3 months)
- Determinants of PET Performance (Clinical/Biological/Imaging)(3 months)
- Prognostic Value of PET Findings for Biological Remission(3 months)