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ACTIVE NOT RECRUITING
NCT07832448
NA

Microsurgical Resection Combined With Photodynamic Therapy for Recurrent Glioblastoma

Sponsor: Yonggao Mou

View on ClinicalTrials.gov

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

DRUG

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.

PROCEDURE

Microsurgical Tumor Resection

Standard craniotomy for microsurgical gross-total or subtotal resection of the recurrent glioblastoma, performed 48 hours after photosensitizer infusion.

DEVICE

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