Prolactinoma
Conditions
Keywords
Dopamine agonist, Dopamine D2 receptors, PET-MR
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.
Interventions
OTHERSurgery
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
DRUGDrug treatment
The medication will continue if DA causes tumors to shrink.
Sponsors
Xinqiao Hospital of Chongqing
First Hospital of China Medical University
Beijing Tiantan Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Fujian Medical University
Peking Union Medical College Hospital
Huashan Hospital
Chinese PLA General Hospital
Zhebao Wu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on PRL level | Up to 6 months | Record the result of PRL on every 3 month follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactWeiting Gu, MD
Backup ContactZhebao Wu, Medical PhD
Outcome results
None listed