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Microsurgical Resection Combined With Photodynamic Therapy for Recurrent Glioblastoma
Sponsor: Yonggao Mou
Summary
This single-center, prospective, single-arm, open-label clinical study evaluates the effectiveness and safety of microsurgical resection combined with photodynamic therapy (PDT) in patients with recurrent glioblastoma (GBM). Patients receive intravenous hematoporphyrin injection (Hiporfin) 5 mg/kg 48-72 hours before surgery. Standard craniotomy with microsurgical resection of the recurrent tumor is then performed, followed by intraoperative irradiation of the resection cavity with a 630-nm semiconductor laser (fluence 150-200 J/cm2). The primary outcome is the rate of tumor recurrence within 2 years after surgery. Participants are followed postoperatively for up to 24 months with contrast-enhanced brain MRI, neurological and quality-of-life assessments (EORTC QLQ-C30), and adverse event monitoring.
Official title: Effectiveness and Safety of Microsurgical Resection Combined With Photodynamic Therapy (PDT) Using Hematoporphyrin Injection (Hiporfin) for Recurrent Glioblastoma: A Prospective, Single-Arm, Open-Label, Single-Center Clinical Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-08-04
Completion Date
2030-12-31
Last Updated
2026-09-22
Healthy Volunteers
No
Interventions
Hematoporphyrin Injection (Hiporfin)
Skin test (scratch or intradermal, 0.01 mg/mL) 2 days before surgery; if negative, hematoporphyrin derivative (HpD) 5 mg/kg in 250 mL normal saline by light-protected intravenous infusion 48-72 hours before surgery.
Microsurgical Tumor Resection
Standard craniotomy for microsurgical gross-total or subtotal resection of the recurrent glioblastoma, performed 48 hours after photosensitizer infusion.
630-nm Semiconductor Laser
Intraoperative irradiation of the resection cavity with a 630-nm semiconductor laser: output power 1 W, power density 120-150 mW/cm2, energy density 150-200 J/cm2, approximately 10-20 minutes, using cylindrical diffuser or flat-cut fiber according to cavity shape.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China