Study on the Safety of Photodynamic Therapy with Aminolevulinic Acid Hydrochloride for Patients Aged 18-75 with Grade IV Glioblastoma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer known as glioblastoma, which is a high-grade form of glioma. The study will explore a treatment involving a drug called Pentalafen, which contains the active substance aminolevulinic acid hydrochloride. This drug is used in combination with a device named Heliance to perform a procedure called photodynamic therapy (PDT). This therapy is applied during surgery to help treat the tumor.

The purpose of the study is to investigate the safety and feasibility of using this treatment method in patients aged 18 to 75 who have been diagnosed with grade IV glioblastoma. Participants will receive the treatment during surgery, and the study will monitor how well the treatment is tolerated and determine the best light dose to use in future trials. The study will also look at how long it takes for the disease to progress after the treatment and gather feedback on the usability of the device used in the procedure.

Throughout the study, participants will be closely monitored for any side effects or adverse events. The study aims to provide valuable information on the potential benefits and risks of using Pentalafen and Heliance in treating glioblastoma, which could lead to improved treatment options for patients with this challenging condition.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study requirements and your agreement to participate.

You must be between 18 and 75 years old and have been newly diagnosed with a type of brain tumor called glioblastoma.

2 pre-surgery assessment

Before surgery, you will undergo an MRI scan to assess the tumor. This scan helps determine if the tumor is suitable for the study procedure.

Your ability to take oral medications will be confirmed, and your overall health will be evaluated to ensure you are eligible for surgery.

3 medication administration

You will receive a medication called Pentalafen, which is a powder that you will take by mouth. This medication is part of the study treatment.

The exact dosage and frequency will be explained to you by the study team.

4 surgery and photodynamic therapy

During surgery, a special light treatment called photodynamic therapy (PDT) will be used. This involves using a device called the Heliance Solution to help treat the tumor.

The goal of this treatment is to assess its safety and how well it can be tolerated.

5 post-surgery follow-up

After surgery, you will be monitored for any side effects or changes in your condition. This is to ensure your safety and to gather information about the treatment’s effects.

You will continue to receive standard care for glioblastoma, which may include additional treatments as planned by your healthcare team.

6 ongoing assessments

Throughout the study, regular check-ups and assessments will be conducted to monitor your health and the progress of the treatment.

These assessments will help determine the effectiveness and safety of the study treatment over time.

Who Can Join the Study?

Participants must be males or females between the ages of 18 and 75 at the time of signing the consent form.
Participants must sign an informed consent form, which means they agree to follow the study’s rules and understand what the study involves.
Participants must have a newly diagnosed GBM (Glioblastoma), which is suspected based on clinical examination and MRI results showing a specific type of brain tumor.
Participants must have a Karnofsky Performance Score of 70 or higher. This score measures the ability to carry out daily activities, with higher scores indicating better function.
Participants must be eligible for surgery, meaning they can safely undergo an operation.
Participants must be able to have the maximum possible tumor removal based on MRI results.
Participants must be planning to receive standard treatment (known as the Stupp Protocol) after surgery.
Participants must be able to take oral medications, meaning they can swallow pills or tablets.
The tumor must be suitable for a PDT procedure (a specific type of treatment) as confirmed by both the study doctor and sponsor based on MRI data before surgery.

Who Cannot Join the Study?

Patients with a different type of brain tumor than high-grade glioma or glioblastoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.06.2025

Trial locations

Investigated drugs:

Aminolevulinic Acid Hydrochloride

Pentalafen® is a medication used in this clinical trial to help treat patients with grade IV glioblastoma, a type of brain cancer. It is used during a procedure called photodynamic therapy (PDT), which involves using light to activate the drug. This activation helps to destroy cancer cells. The goal of using Pentalafen® in this trial is to see if it is safe and can be tolerated by patients when used in combination with light therapy during surgery.

Heliance® Solution is a device used in the clinical trial to deliver light during the photodynamic therapy (PDT) procedure. This device works together with the Pentalafen® drug to help treat the brain cancer by activating the drug with light. The light from the Heliance® Solution helps to target and destroy the cancer cells. The trial aims to determine if this combination of light and drug therapy is safe and feasible for patients with grade IV glioblastoma.

Investigated diseases:

High-grade glioma – High-grade glioma is a type of brain tumor that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and aggressive behavior, often infiltrating surrounding brain tissue. As the tumor progresses, it can cause symptoms such as headaches, seizures, and neurological deficits depending on its location. The tumor’s growth can lead to increased pressure within the skull, affecting brain function. High-grade gliomas are known for their tendency to recur even after treatment. They are classified as grade III or IV tumors, with grade IV being the most aggressive form.

Glioblastoma – Glioblastoma, also known as glioblastoma multiforme, is the most aggressive form of high-grade glioma. It is a fast-growing brain tumor that arises from astrocytes, a type of glial cell. Glioblastomas are highly invasive, often spreading into nearby brain tissue, which makes them difficult to remove completely. As the tumor enlarges, it can cause symptoms such as persistent headaches, nausea, vomiting, and changes in personality or cognitive function. The tumor’s rapid progression can lead to significant neurological impairment. Glioblastomas are classified as grade IV tumors, indicating their high level of malignancy.

Trial ID:

2025-520563-41-00

Protocol code:

HTX-GBM-01

NCT ID:

NCT05736406

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety of Photodynamic Therapy with Aminolevulinic Acid Hydrochloride for Patients Aged 18-75 with Grade IV Glioblastoma

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