glioblastoma
Conditions
Interventions
FUS group:Low Intensity Focused Ultrasound Combined with Microbubbles
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, able and willing to provide written informed consent, and able to comply with study procedures during the study period; 2. Patients with newly diagnosed or recurrent glioblastoma presenting as a single intracranial lesion on preoperative MRI/CT, with the maximum tumor diameter = 70); 9. For patients of reproductive potential: negative pregnancy test within 14 days prior to enrollment and agreement to use adequate contraception during the study, including up to 6 months after intraoperative administration of albumin-bound paclitaxel; 10. For recurrent patients: imaging evidence of tumor recurrence, with the first surgery pathologically confirmed as glioblastoma (IDH wild-type or IDH mutant), and at least 12 weeks since completion of the most recent radiotherapy at the time of enrollment;
Exclusion criteria
Exclusion criteria: 1. Patients with multifocal disease that cannot be covered by the ultrasound field: lesions separated by >70 mm or tumors located in the posterior fossa; 2. Patients at risk of surgical site infection (e.g., having undergone >=2 prior craniotomies, neurosurgery within the past 3 months, poor skin condition, and/or prior surgical site infection) or at risk of cranial wound dehiscence; 3. Clinical evidence of peripheral neuropathy at the time of screening; 4. Receipt of any other investigational drug within 4 weeks prior to enrollment; 5. Prior treatment with paclitaxel or compounds with similar chemical or biological composition, history of hypersensitivity to such agents, or known allergy to the gadolinium-based contrast agent to be used; 6. Contraindications to albumin-bound paclitaxel; 7. Uncontrolled epilepsy; 8. Evidence of elevated intracranial pressure; 9. Pregnancy or breastfeeding; 10. Known intracranial aneurysm or history of spontaneous intratumoral hemorrhage; 11. Presence of coils, clips, shunts, intravascular stents, and/or non-removable implants, non-absorbable dural substitutes, or reservoirs; 12. Medical need for ongoing antiplatelet therapy; 13. Known or suspected active or chronic infection; 14. Infection requiring intravenous therapy, or unexplained fever (temperature >=37.5°C); 15. Unstable or uncontrolled systemic disease or relevant medical history, including diabetes, current or past organic cardiovascular or cerebrovascular disease, heart failure (NYHA class >=2), hypertension (grade >=2), cardiac conduction block of grade I or higher, history of myocardial infarction or myocarditis, pulmonary dysfunction, thyroid dysfunction, known right-to-left shunt, severe pulmonary arterial hypertension (pulmonary arterial pressure >90 mmHg), uncontrolled systemic hypertension, adult respiratory distress syndrome (with risk of microbubble reaction), or cerebrovascular events (e.g., stroke) within the past 6 months; 16. Active autoimmune disease or history of autoimmune disorders, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener’s granulomatosis; 17. Planned or required administration of any live vaccine during the screening or treatment period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma albumin-bound paclitaxel concentration;Restoration of the blood–brain barrier at 24 hours postoperatively, assessed by contrast-enhanced brain magnetic resonance imaging (MRI).;Intratumoral albumin-bound paclitaxel concentration; | — |
Countries
China
Contacts
Public ContactZhifeng Shi
Huashan Hospital, Fudan University
Outcome results
None listed