Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.

Conditions
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Prolactinoma

Intervention / Treatment
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* Other: Surgery
* Drug: Drug treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug treatment<br>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. | Drug: Drug treatment<br>* The medication will continue if DA causes tumors to shrink.<br>|
| Experimental: Surgery<br>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. | Other: Surgery<br>* The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on PRL level | Record the result of PRL on every 3 month follow-up visit | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 visits | Up to 6 months | 
| Change from baseline of visual field scale | Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind | Up to 6 months | 
| Change from baseline of visual acuity | Record the Visual acuity on every 3 month follow-up visit. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dopamine agonist, Dopamine D2 receptors, PET-MR