Astrocytoma malignant Trials in Disease

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

This clinical trial is investigating a novel treatment approach for patients who have been newly diagnosed with high-grade glioma, an aggressive type of brain tumor that grows quickly. The study focuses on combining a substance called 5-aminolevulinic acid with a technique known as sonodynamic therapy, which uses ultrasound waves to potentially enhance treatment effectiveness.

Main Inclusion Criteria:

• Patients must be at least 18 years old
• Must have a WHO Performance Status of 0-2, meaning they are either fully active or have some symptoms but can still perform self-care activities
• Must have brain imaging showing typical signs of high-grade glioma, or a confirmed diagnosis including types such as glioblastoma, anaplastic astrocytoma, or anaplastic oligodendroglioma
• Should not have received previous tumor treatments such as surgery (except biopsy), radiation, chemotherapy, or other therapies
• Must be planning to undergo surgery to remove as much of the tumor as possible
• Must meet specific laboratory requirements including adequate blood counts, liver function, and kidney function
• Patients of childbearing potential must agree to use highly effective birth control during the study period

Main Exclusion Criteria:

• Patients who have been previously diagnosed with high-grade glioma and are not newly diagnosed
• Patients who fall outside the specified age range
• Patients who do not meet the clinical trial group requirements
• Patients considered part of vulnerable populations who may have limited ability to protect their own interests

Focus and Goal:

The primary purpose of this study is to evaluate the safety and tolerability of combining 5-aminolevulinic acid with sonodynamic therapy in newly diagnosed patients. The medication is administered as an oral solution that patients take by mouth. After administration, ultrasound therapy is applied using a delivery system called CV01. The study monitors participants for any side effects or adverse reactions over a 28-day period following treatment.

Throughout the trial, regular check-ups and tests are conducted to ensure patient safety. MRI scans are used to observe changes in the tumor both before and after treatment. The study also examines how the treatment affects tumor cells at a microscopic level. This monitoring approach helps researchers understand not only the safety profile but also the potential effectiveness of this innovative combination therapy.

Investigational Drugs:

The trial uses 5-aminolevulinic acid (5-ALA), marketed as Gliolan, at a concentration of 30 mg/ml in oral solution form. This medication works by converting into a compound that accumulates specifically in tumor cells, making them more sensitive to ultrasound waves. When combined with the CV01 ultrasound delivery system, the treatment aims to target and potentially destroy cancer cells more effectively. The molecule acts as a photosensitizing agent, helping to make tumor cells more visible and potentially more vulnerable to the therapeutic effects of ultrasound.