Intracranial malignant tumor
Conditions
Interventions
Test group:Laser ablation
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) 18 years old =80 years old; (2) Previously diagnosed or newly diagnosed intracranial malignant tumors, such as brain glioma and brain metastases; (3) Lesions could be identified in enhanced MRI images, with the number of lesions =4 and the diameter of a single lesion =3.0cm; (4) There is no indication for craniotomy surgery or craniotomy surgery may cause serious postoperative complications; (5) KPS score =60; (6) Informed consent to the test before the test, and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) MRI contraindicated patients; (2) The expected survival time is less than 6 months; (3) serious coagulation dysfunction; (4) Evidence of severe or uncontrolled systemic disease; (5) Women who are pregnant or breastfeeding, or women or men who wish to give birth within 6 months; (6) mental abnormality, unable to cooperate with the examination; (7) Participants had participated in other medical device clinical trials one month before screening; Have participated in drug clinical trials within 3 months before the screening period; (8) Any other conditions deemed unsuitable for participation in this trial by the investigator, such as non-malignant tumors, systemic metastases that seriously affect survival, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of target lesion ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total ablation rate of target lesion;Ablation success rate;Ablation time;KPS score;Software planning under the optical fiber placement once in place success rate;Local control rate of target lesions;NIHSS score;Instrument use satisfaction evaluation;Postoperative complication;Vital signs: temperature, pulse, respiration, blood pressure;Laboratory examination;Equipment failure rate;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactMao Ying
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed