The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Change from baseline on PRL level
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: 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.
Intervention: Surgery (Other)
Outcomes
Primary Outcomes
Change from baseline on PRL level
Time Frame: Up to 6 months
Record the result of PRL on every 3 month follow-up visit
Secondary Outcomes
- 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)
Investigators
Zhebao Wu
Principal Investigator
Ruijin Hospital