Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT02536261
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
70 Years
Study:
NCT02536261
Study Brief:
Protocol Section:
NCT02536261