The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Change from baseline on tumor volume
研究概览
简要总结
To study the in vivo expression of dopamine D2 receptors in nonfunctioning pituitary adenoma and the predictive role of dopamine dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists（DA）.
详细描述
Dopamine agonists are the first line therapy for prolactinoma,which are also effective in some cases of other subtypes of pituitary tumors. It had been showed that dopamine agonists inhibit prolactin secretion by binding to and activating dopamine D2 receptors. PET-MR combined MR images with PET function images is substantial to evaluate the expression of dopamine D2 receptors.The aim is to study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal serum pituitary hormone levels or mild increase of serum prolactin.
- •Enhanced MRI shows a pituitary tumor and tumor diameter>1cm.
- •Aged between 18 and 65 years old, either sex.
- •Karnofsky performance status ≥
- •The patient has signed the informed consent.
排除标准
- •Patients concomitantly taking the psychotropic drugs.
- •Patients with parkinson disease and is taking dopaminergic agents.
- •Patients with pituitary adenoma who received Gamma knife treatment.
- •Pregnant or lactating women.
- •Patients with poor compliance, who cannot implement the program strictly.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
- •Patients with claustrophobia. -
研究组 & 干预措施
Drug treatment
Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.
干预措施: Drug treatment (Drug)
Surgery
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.
干预措施: Surgery (Other)
结局指标
主要结局
Change from baseline on tumor volume
时间窗: Up to 6 months]
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）. Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visit.
次要结局
- Change from baseline of visual acuity(Up to 6 months)
- Change from visual field scale(Up to 6 months)
研究者
Zhebao Wu
Principal Investigator
Ruijin Hospital