18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensitivity of FET PET results in comparison to histopathology
研究概览
简要总结
The purpose of this research is to evaluate the performance [sensitivity, specificity, accuracy] of FET PET/CT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.
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
- •Patients must meet ALL criteria listed below for entry:
- •Biochemically diagnosed ACTH-dependent Cushing disease.
- •No previous pituitary surgery.
- •Planned to undergo pituitary surgery for localization/resection of adenoma.
- •No contraindications for PET/CT.
- •Recent (within 3 months) pituitary MR, or pending pituitary MR to be performed as close as possible to FET PET/CT.
- •Age ≥ 18 years.
- •Ability to provide informed consent.
排除标准
- •Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
- •Declining to use effective contraceptive methods during the study (for individuals of child-bearing potential)
- •Need for emergent surgery that would be delayed by participation
- •Bacterial, viral, or fungal infections requiring systemic therapy
- •Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and/or protocol objectives
- •Known diagnosis of autoimmune disorders
- •Patients receiving any other investigational agent within the past 28 days
- •Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the FET injection.
- •Known hypersensitivity to any excipients used in FET
研究组 & 干预措施
(ACTH)-dependent Cushing disease
Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment
干预措施: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET (Drug)
结局指标
主要结局
Sensitivity of FET PET results in comparison to histopathology
时间窗: Baseline
Percentage of cases where surgical findings and pathology are in agreement with \[18F\]FET-PET/MRI imaging
Specificity of FET PET results in comparison to histopathology
时间窗: Baseline
Accuracy of FET PET results in comparison to histopathology
时间窗: Baseline
次要结局
- Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR(Baseline)
研究者
Derek R. Johnson
Principal Investigator
Mayo Clinic