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临床试验/NCT03404414
NCT03404414Unknown1 期

Detection of Functioning Pituitary Microadenoma With Inconclusive MRI Findings: PET/MRI Versus PET/CT

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
100
试验地点
1
主要终点
Standardized uptake value of 18F-FDG in pituitary adenoma

研究概览

简要总结

This is a prospective case-control study to compare the usefulness of 18F-FDG PET/MRI with that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas.A single dose of 370 Mega-Becquerel (MBq) 18F-FDG will be injected intravenously.Visual and semiquantitative method will be used to assess the PET/MRI and PET/CT images.

详细描述

Magnetic resonance imaging (MRI) may be insufficient to locate functioning pituitary microadenoma.This study compared the usefulness of 18F-FDG PET/MRI with that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas in patients with inconclusive conventional MRI findings. Trans-sphenoidal adenomectomy was performed within 2 weeks of imaging.The PET/CT and PET/MRI findings and tracer uptake levels were correlated with the surgical findings and pathological results.

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

盲法说明

None (Open Label)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were pathologically diagnosed with pituitary adenoma after surgery were recruited, and were able to provide basic information and sign the written informed consent form.

排除标准

  • The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

研究组 & 干预措施

18F-FDG PET/MRI and 18F-FDG PET/CT

Experimental

The patients were injected with 370 MBq of 18F-FDG in one dose intravenously and underwent PET/MRI or PET/CT scan 1 hour later

干预措施: 18F-FDG (Drug)

结局指标

主要结局

Standardized uptake value of 18F-FDG in pituitary adenoma

时间窗: 5 years

The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in pituitary adenoma will be measured

次要结局

  • Adverse events collection(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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