Radiation-Induced Brain Injury, RIBI
Conditions
Interventions
Experimental group:Edaravone and Dexborneol Concentrated Solution for Injection
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Received radiotherapy >= 12 months prior to enrollment; 3.Imaging evidence supporting the diagnosis of radiation-induced brain injury (RIBI) with no tumor recurrence; 4.Presence of high-risk side effects, contraindications, or inefficacy to glucocorticoid and bevacizumab therapy within the 12 months prior to enrollment; 5.Expected survival > 12 months; 6.Normal blood routine, liver and kidney function, and coagulation function; 7.Adequate language ability and cognitive function to complete the study questionnaires;
Exclusion criteria
Exclusion criteria: 1. Evidence of tumor recurrence, metastasis, or invasion 2. Currently using bevacizumab 3. Currently using glucocorticoids 4. Currently undergoing hyperbaric oxygen therapy 5. Presence of obvious intracranial hypertension symptoms requiring treatment with dehydrating agents such as mannitol 6. Presence of brain herniation risk requiring surgical intervention 7. History of mental illness 8. History of seizures 9. History of atherosclerotic cardiovascular disease within 6 months (including myocardial infarction, unstable angina, stroke) 10. Heart failure: New York Heart Association (NYHA) class II or higher congestive heart failure 11. Severe and poorly controlled arrhythmia 12. History of vascular disease (such as moderate to severe carotid artery stenosis, aortic aneurysm, aortic dissection) 13. Severe infection 14. Relevant drug allergy history 15. Planning pregnancy or breastfeeding within 12 months 16. Current or past peripheral neuropathy 17. Abnormal liver or kidney function 18. Active pulmonary tuberculosis 19. History of organ transplantation 20. Human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a >=25% reduction in brain edema volume on FLAIR-MRI at 3 months after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in LENT/SOMA scale scores; | — |
Countries
China
Contacts
Public ContactZhigang Liu
Dongguan People's Hospital
Outcome results
None listed