Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus (NCT02536261) | Clinical Trial Compass
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Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
China30 participantsStarted 2016-06
Plain-language 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The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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.
Who can participate
Age range15 Years – 70 Years
SexALL
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Inclusion criteria
✓. Aged between 15 and 70 years old, either sex;
✓. Karnofsky performance status ≥ 70;
✓. 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;
✓. 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 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;
✕. Patients who use any dopamine receptor agonists other than bromocriptine and cabergoline;
✕. Patients taking the other prolactinomas simultaneously;
✕. pregnant or lactating women, or women preparing pregnant;