Not recruitingRare disease

Study on the Safety of Aminolevulinic Acid with Ultrasound Therapy for Patients with Newly Diagnosed High-Grade Glioma Before Surgery and Standard Treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of fast-growing brain tumor known as high-grade glioma. The trial will explore the safety of a treatment that combines a substance called 5-aminolevulinic acid (5-ALA) with a method called sonodynamic therapy (SDT), which uses ultrasound waves. The treatment is intended for patients who have been newly diagnosed with high-grade glioma and are scheduled for surgery to remove the tumor, followed by standard therapy.

The purpose of the study is to evaluate how safe and tolerable this new treatment is for patients. Participants will receive the treatment in the form of an oral solution, which means it is taken by mouth. The study will monitor patients for any side effects or adverse reactions for a period of 28 days after the treatment is administered. This monitoring will include regular check-ups and tests to ensure the safety of the participants.

Throughout the study, changes in the tumor will be observed using MRI scans, which are imaging tests that help doctors see inside the body. The study will also look at how the treatment affects the tumor at a cellular level. This trial aims to provide valuable information about the potential of 5-ALA combined with SDT as a treatment option for high-grade glioma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and medical history related to high-grade glioma.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment is conducted, including a cranial MRI to evaluate the brain tumor.
Laboratory tests are performed to check blood counts, liver function, and other health indicators.
Step 3
Medication administration
The medication Gliolan is administered as an oral solution. It contains aminolevulinic acid hydrochloride at a concentration of 30 mg/ml.
The dosage and frequency are determined by the study protocol, focusing on safety and tolerability.
Step 4
Sonodynamic therapy (SDT)
Following medication administration, sonodynamic therapy (SDT) is performed using ultrasound technology.
This step aims to evaluate the safety and potential effects of the therapy on the tumor.
Step 5
Monitoring and follow-up
For 28 days after the SDT, monitoring occurs to observe any adverse events or side effects.
Regular assessments include physical examinations and laboratory tests to ensure safety.
Step 6
Final evaluation
A final evaluation is conducted, including a follow-up MRI to assess changes in the tumor.
The study concludes with a comprehensive review of all collected data to determine the safety and potential efficacy of the treatment.

Who can join the trial?

13 criteria

Must be **18 years or older**.
Have a **WHO Performance Status** of 0-2, which means the patient is fully active or has some symptoms but can still take care of themselves.
Have a **cranial MRI** showing typical signs of a high-grade glioma, or have a confirmed diagnosis of high-grade glioma, including types like GBM, anaplastic astrocytoma (AA), or anaplastic oligodendroglioma (AO). The patient should not have had any specific tumor treatments like surgery (except for a biopsy), radiation, chemotherapy, or other therapies.
Plan to have **debulking or cytoreductive surgery**, which is a type of surgery to remove as much of the tumor as possible.
Meet certain **laboratory test values** at the start of the study:
- **Absolute neutrophil count (ANC)** of at least 1500 cells/mm³.
- **Platelet count** of at least 100,000 cells/mm³.
- **Hemoglobin (Hgb)** level greater than 10g/dL.
- **AST and ALT** levels no more than 2.5 times the upper limit of normal.
- **Total bilirubin** level no more than 1.5 times the upper limit of normal.
- **Creatine clearance (CrCL)** of at least 40 mL/min, which is a measure of kidney function.
- **Blood clotting** within acceptable limits as determined by the study doctor.
- For both female and male patients, and their female partners who can have children: Must agree to use **highly effective birth control** during the study. Female patients should continue for 6 months after the last dose of Gliolan®, and male patients and their female partners should continue for 3 months after the last dose.
- Must be able to **understand and give informed consent**, meaning they understand the study and agree to participate.

Who cannot join the trial?

5 criteria

Patients who are not newly diagnosed with high grade glioma cannot participate. High grade glioma is a type of brain tumor.
Patients who are outside the specified age range cannot participate. The age range includes children and adults.
Patients who are not part of the specified clinical trial groups cannot participate.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are considered part of a vulnerable population may be excluded. A vulnerable population includes groups who may have limited ability to protect their own interests.

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Verified sites

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Universitaetsklinikum Muenster AöR
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Munster, Germany

Trial locations

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Investigated drugs

5-Aminolevulinic Acid (5-ALA)
is a medication used in this trial to help make cancer cells more visible. It is given to patients before they undergo a special type of therapy. The goal is to improve the ability to target and treat high-grade glioma, a type of brain cancer.
CV01
is a delivery method used in this trial to apply ultrasound therapy. It works together with 5-ALA to perform sonodynamic therapy (SDT). This therapy aims to enhance the treatment of high-grade glioma by using sound waves to activate the medication, potentially improving its effectiveness in targeting cancer cells.

Aminolevulinic Acid Hydrochloride

What is already known about the treatment

5-Aminolevulinic Acid (5-ALA) – This medication is administered orally and is used in combination with ultrasound for sonodynamic therapy. It is currently being studied in clinical trials for its safety and effectiveness in treating high-grade glioma, a type of brain tumor. The main therapeutic indication is to assist in the treatment of this aggressive cancer. At the molecular level, 5-ALA is converted into a compound that accumulates in tumor cells, making them more sensitive to light and ultrasound, which helps in targeting and destroying the cancer cells. It is classified as a photosensitizing agent used in photodynamic therapy.

Investigated diseases

High Grade Glioma – High grade glioma is a type of brain tumor that originates from glial cells, which are supportive cells in the brain. These tumors are known for their aggressive nature and rapid growth. They can infiltrate surrounding brain tissue, making them difficult to remove completely through surgery. As the tumor grows, it can cause symptoms such as headaches, seizures, and neurological deficits depending on its location in the brain. The progression of high grade glioma often involves increased tumor size and potential spread to other parts of the brain. This condition is considered rare and requires specialized medical attention.