Non Invasive Imaging Methods for Detecting Primary Aldosteronism： a Clinical Positron EmissionTomography (PET) Study of 18F-Pentixather
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA
研究概览
简要总结
Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. [18F]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent([18F]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. [18F]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram [ID/g] at 1 hour post injection[p.i.]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of [18F]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the [18F]AlF-NOTA-Pentixather as a probe for APA.
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 diagnosed with primary aldosteronism and willing to undergo surgery
- •Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
- •Postoperative recurrence in patients with primary aldosteronism
排除标准
- •Pregnant and lactating women.
- •Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
- •There are other situations where patients are not suitable for this examination
结局指标
主要结局
Measurement of radiation dosimetry and biodistribution of 18F-Pentixather determined with PET/CT in Patients with PA
时间窗: 6 month
Images were acquired using a Biograph Truepoint 64 PET/CT scanner (Siemens, Erlangen, Germany).The dosimetry analysis was performed using 3d-slicer（version 5.6.1, with slicerOpenDose3D module (https://gitlab.com/opendose/opendose3d). OpenDose: open access resources for nuclear medicine dosimetry (www.opendose.org).
Analyze the specificity and sensitivity of 18F-pentixather PET/CT for the diagnosis of APA
时间窗: 3 years
Compare the 18F-Pentixather SUVmax with the CXCR4，CYP11B2 immunohistochemical score. Calculate the sensitivity and specificity of 18F-pentixafor PET/CT results for an indication of APA, IAH, or NFA lesions.
次要结局
未报告次要终点
研究者
Fangfang Sun
Pharmacist
The First Affiliated Hospital of Dalian Medical University