Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

Not Applicable

• Conditions: Prolactinoma
• Interventions: Drug: Drug treatment; Other: Surgery

• Registration Number: NCT03717454
• Lead Sponsor: Zhebao Wu

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-24
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20
• Study Start: 2018-12-01
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Hyperprolactinemia;
2. Enhanced pituitary MRI shows sella regional tumor;
3. Aged between 18 and 65 years old, either sex;
4. Karnofsky performance status ≥ 70;
5. The patient has signed the informed consent.

Exclusion Criteria

1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
2. Patients with parkinson disease and is taking dopaminergic agents;
3. Patients with prolactinoma who received Gamma knife treatment;
4. Pregnant or lactating women, or women preparing pregnant;
5. Patients with poor compliance, who cannot implement the program strictly.
6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
7. Patients with claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug treatment	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.
Surgery	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline on PRL level	Up to 6 months	Record the result of PRL on every 3 month follow-up visit

Secondary Outcome Measures

Name	Time	Method
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）	Up to 6 months	Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
Change from baseline of visual field scale	Up to 6 months	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
Change from baseline of visual acuity	Up to 6 months	Record the Visual acuity on every 3 month follow-up visit.