Clinical trial · Observational
Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study
Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Radiation Necrosis | — | UNRESOLVED | — |
| MRI | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- group one will receive non-GM1 conservative therapy
- description
- Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy
- interventionNames
- Drug: GM1
Primary outcomes (1)
- measure
- The necrotic volume showed on MRI
- timeFrame
- 6-8 months
Secondary outcomes (1)
- measure
- relief of the symptoms related to CRN
- timeFrame
- 6-8 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months. Exclusion Criteria: * CRN combined with local or regional relapse, or with distant metastasis. ② CRN combined with other cerebrovascular disease. ③CRN combined with the second primary malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes. ⑥CRN patients that were supposed to live less than 6 months.
References
Publications (0)
Data not yet available