Clinical Trial: A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Condition: Primary Glioblastoma
Study Type: INTERVENTIONAL
Official Title: An Interventional, Non-randomized, Phase 1/2, Light Dose-escalation Study to Investigate the Safety and Feasibility of Intraoperative Photodynamic Therapy (PDT) With Pentalafen® Drug and Heliance
Brief Summary:
The primary objective of this clinical trial is to determine the safety and tolerability of two doses of light in intraoperative PDT added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 69 with newly diagnosed glioblastoma.This treatment will be carried out in addition to the maximal surgical resection.Data collected during this trial will be used to design the upcoming pivotal study .The study will utilize an independent Data and Safety Monitoring Board (iDSMB) that…
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