The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.
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 PRL level
研究概览
简要总结
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.
详细描述
The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA 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 DA.
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
- •Hyperprolactinemia;
- •Enhanced pituitary MRI shows sella regional tumor;
- •Aged between 18 and 65 years old, either sex;
- •Karnofsky performance status ≥ 70;
- •The patient has signed the informed consent.
排除标准
- •Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
- •Patients with parkinson disease and is taking dopaminergic agents;
- •Patients with prolactinoma who received Gamma knife treatment;
- •Pregnant or lactating women, or women preparing pregnant;
- •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 are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume,visual acuity and visual field scale will be measured every 3 months.MRI showed that the tumors shrunk significantly.
干预措施: Drug treatment (Drug)
Surgery
Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The CAB or BC fail to decrease prolactinoma size.
干预措施: Surgery (Other)
结局指标
主要结局
Change from baseline on PRL level
时间窗: Up to 6 months
Record the result of PRL on every 3 month follow-up visit
次要结局
- Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）(Up to 6 months)
- Change from baseline of visual field scale(Up to 6 months)
- Change from baseline of visual acuity(Up to 6 months)
研究者
Zhebao Wu
Principal Investigator
Ruijin Hospital