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An interventional, multicenter, and international phase 1/2, light-dose-escalation study to investigate the safety and feasibility of intraoperative photodynamic therapy (PDT) with Pentalafen® drug and Heliance® Solution device in male and female patients 18 to 75 years of age with grade IV glioblastoma.
EU CTIS ID: 2025-520563-41-00
What this study is testing
Safety and tolerability of intraoperative PDT regimen in patients with GBM by determining the MTD and the recommended dose light for the pivotal trial.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females must be between 18, or legal age of consent, and 75 years of age (both included) at the time of signing informed consent.
- Signed informed consent which includes compliance with requirements and restrictions listed in the informed consent.
- Newly diagnosed GBM, presumed on the basis of clinical and MRI criteria (intra-axial brain tumor with peripheral rim contrast enhancement).
- Karnofsky Performance Score ≥70
- Eligible for surgery
- Amenable to maximal tumor resection based on MRI
You likely can't join if
- a. Patient with bifocal or multifocal disease, assessed on MR1I T1Gd enhanced. b. Patient with tumor of deep location such as tumor involving the corpus callosum, the basal ganglia, the brain stem, or tumor involving the midline as assessed on MRI. c. Patient with prior brain surgery other than stereotactic biopsy
- Known allergic reactions or hypersensitivity to egg, soya, or peanut proteins.
- Febrile illness
- Contraindication to 5-ALA HCl administration, including: a) Porphyria b) Taking photosensitizing drugs 24 hours before and 14 days after the administration of Pentalafen® including but not limited to: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, tetracyclines, and topical preparations containing ALA c) Inability to suspend a long-term hepatotoxic treatment (such as, but not limited to diclofenac, fenofibrate, carbamazepine for 24 hours after 5-ALA HCl intake.
- Contraindication to MRI examination (e.g., MRI-incompatible pacemaker)
- Treatment with another investigational drug or intervention within 30 days prior to or during the entire study
See the full eligibility criteria
Who can join
- Males or females must be between 18, or legal age of consent, and 75 years of age (both included) at the time of signing informed consent.
- Signed informed consent which includes compliance with requirements and restrictions listed in the informed consent.
- Newly diagnosed GBM, presumed on the basis of clinical and MRI criteria (intra-axial brain tumor with peripheral rim contrast enhancement).
- Karnofsky Performance Score ≥70
- Eligible for surgery
- Amenable to maximal tumor resection based on MRI
- Planned to receive SOC (i.e., Stupp Protocol) treatment after surgery
- Ability to take oral medications
- Tumor eligible to PDT procedure as validated by both investigator and sponsor based on pre-operative MRI data
What rules you out
- a. Patient with bifocal or multifocal disease, assessed on MR1I T1Gd enhanced. b. Patient with tumor of deep location such as tumor involving the corpus callosum, the basal ganglia, the brain stem, or tumor involving the midline as assessed on MRI. c. Patient with prior brain surgery other than stereotactic biopsy
- Known allergic reactions or hypersensitivity to egg, soya, or peanut proteins.
- Febrile illness
- Contraindication to 5-ALA HCl administration, including: a) Porphyria b) Taking photosensitizing drugs 24 hours before and 14 days after the administration of Pentalafen® including but not limited to: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, tetracyclines, and topical preparations containing ALA c) Inability to suspend a long-term hepatotoxic treatment (such as, but not limited to diclofenac, fenofibrate, carbamazepine for 24 hours after 5-ALA HCl intake.
- Contraindication to MRI examination (e.g., MRI-incompatible pacemaker)
- Treatment with another investigational drug or intervention within 30 days prior to or during the entire study
- Predictable non-compliance with the rules for preventing the transient risk of skin photosensitization.
- Clinical follow up not possible for psychological, family, social, or geographic reasons.
- Legal incapacity
- Pregnancy or lactation
- Women of childbearing potential (WOCBP) and males with WOCBP partners not willing to use an effective contraceptive method from inclusion until end of study
- Patient with Lynch syndrome
- Patient with Li-Fraumeni syndrome
- Debilitating cardiopulmonary disease, unstable Type 1 or Type 2 diabetes (treated or not)
- History or current condition of another malignancy (excluding basal cell carcinoma, or carcinoma in-situ) unless treated and off all active therapy for more than 5 years.
- Clinically significant abnormal ECG results, including a corrected QT interval QTc > 480 ms.
- Creatinine clearance < 60 mL/min
- Severe hepatic impairment (bilirubin > 1.5 x the upper limit of normal [ULN] or alkaline phosphatase or transaminases (AST, ALT) > 2.5 x ULN)
- Known allergic reactions to silicone.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.