Invasive Prolactinomas Involving the Cavernous Sinus
Conditions
Keywords
Prolactinoma, dopamine agonist, withdrawal, cavernous sinus
Brief summary
The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological treatment.
Detailed description
For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown. The study objects are patients with invasive prolactinomas involving the cavernous sinus, which were invaded the cavernous sinus to an extent corresponding to Grade III or IV, according to the classification scheme of Knosp and colleagues, who had undergone pharmacological treatment including bromocriptine or cabergoline. Observation will be started after drug withdrawal criteria are reached (PRL remains normal level for no less than two years; tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve),the patients are randomized to withdrawal group or continue treatment group.Observational items include changes of PRL level, tumor volume as well as vision acuity and visual fields. If elevated PRL or tumor relapse is observed, pharmacological treatment will be restarted.
Interventions
None listed
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
Zhebao Wu
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 15 and 70 years old, either sex; 2. Karnofsky performance status ≥ 70; 3. Patients who were suffered Invasive prolactinomas involving the cavernous sinus , referring to ①Serum prolactin level\>200ng/ml, or \>4000mIU/L;②enhanced Magnetic Resonance images confirm tumor invasion into cavernous sinus, i.e. Knosp grade Ⅲ or Ⅳ, and were treated by dopamine agonists treatment; 4. PRL remains normal level for no less than two years; 5. Tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve; 6. 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. Patients who use any dopamine receptor agonists other than bromocriptine and cabergoline; 5. Patients taking the other prolactinomas simultaneously; 6. pregnant or lactating women, or women preparing pregnant; 7. Patients with poor compliance, who cannot implement the program strictly.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on PRL level | Up to 2 years | 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 2 years | Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits |
| Change from baseline of visual acuity | Up to 2 years | Record the Visual acuity on every 3 month follow-up visit |
| Change from baseline on 5 point visual field scale | Up to 2 years | 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 |
Countries
China
Contacts
Primary ContactZhebao Wu, Medical PhD
Outcome results
None listed