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临床试验/NCT07340437
NCT07340437已完成不适用

Clinical Study of an ¹⁸F-labeled GLP-1R Probe in Insulinoma

Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Correlation between clinical indicators and PET/CT results

研究概览

简要总结

The goal of this observational study is to evaluate the diagnostic value of ¹⁸F-Exendin-4 PET/CT imaging in renal insulinoma. Participants will undergo clinical evaluation and ¹⁸F-Exendin-4 PET/CT examination.

详细描述

Early detection, precise diagnosis, and accurate localization are key to the effective management of insulinoma, the most common functional pancreatic neuroendocrine tumor, which is predominantly benign. Histopathological examination remains the diagnostic gold standard, but invasive procedures such as biopsy carry risks of bleeding and hematoma, while rarer complications like infection or pancreatic fistula may also occur. Therefore, there is an urgent clinical need for a highly accurate, non-invasive diagnostic method.

The glucagon-like peptide-1 receptor is overexpressed in insulinomas, making GLP-1R-targeted imaging a major focus in the molecular imaging of this disease. Exendin-4, an analog of GLP-1R agonists, has been shown to specifically bind to GLP-1R when labeled with ⁶⁸Ga, enabling targeted diagnosis of insulinoma. However, compared to ⁶⁸Ga, ¹⁸F offers significant advantages. Although ¹⁸F-labeled exendin-4 has been explored in preclinical studies, its clinical translation has not yet been reported. Therefore, investigating the imaging performance of ¹⁸F-exendin-4 PET/CT in insulinoma is of high clinical relevance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • biochemically confirmed hyperinsulinemic hypoglycemia (plasma glucose < 3.0 mmol/L, insulin > 3 μIU/mL, C-peptide > 0.6 ng/mL)
  • surgical or biopsy-confirmed insulinoma or non-insulinoma pancreatogenous hypoglycemia syndrome, with definitive clinical diagnosis at discharge and comprehensive evaluation for hypoglycemia etiology during hospitalization.

排除标准

  • unknown etiology of hypoglycemia at last follow-up
  • patients clinically diagnosed with insulinoma but without subsequent surgical intervention or biopsy

结局指标

主要结局

Correlation between clinical indicators and PET/CT results

时间窗: 2 years

Correlation analysis of clinical biochemical indicators, endoscopic ultrasound, contrast-enhanced CT, contrast-enhanced MRI with ¹⁸F-Exendin-4 PET/CT results.

次要结局

未报告次要终点

研究者

发起方
Sichuan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Wang

Principal Investigator

Sichuan Provincial People's Hospital

研究点 (1)

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