Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)

Study Overview
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Brief Summary
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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）.

Detailed Description
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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.

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 Nonfunctioning Pituitary Adenoma

Conditions
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Pituitary Adenoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ≥ 70. The patient has signed the informed consent. Exclusion Criteria: 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. -

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 who show high expression of dopamine D2 receptors in PET-MR imaging. | Drug: Drug treatment<br>* Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The medication will be stopped if failure to decrease tumor size and the subjects will be advised to surgical therapy.<br>|
| Experimental: Surgery<br>Subjects who show low expression of dopamine D2 receptors in PET-MR imaging. | Other: Surgery<br>* Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with 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 tumor volume | 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. | Up to 6 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of visual acuity | Record the Visual acuity on every 3 month follow-up visit. | Up to 6 months | 
| Change from visual field scale | 2.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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dopamine D2 Receptors, Nonfunctioning Pituitary Adenoma, Dopamine Agonist, PET-MR