Trials / Completed
CompletedNCT06665724
Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401)
A Phase 1 Single Center Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Universität Münster · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is designed to evaluate safety and explore possible efficacy of 5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®) with CV01 delivery of ultrasound for sonodynamic therapy in patients with newly diagnosed high-grade glioma prior to resection and standard adjuvant therapy. The study will accrue 10 evaluable high-grade glioma patients. Patients who qualify will receive sonodynamic therapy (5 ALA combined with CV01-delivered sonication) 2 to 5 days prior to standard resection, with one study magnetic resonance imaging being performed between sonodynamic therapy and resection. Resection will be followed by standard radio-/chemotherapy. All patients will be followed up in-study for toxicities and adverse events for 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 5-Aminolevulinic acid Hydrochloride (Gliolan®) | Patients will receive 5-Aminolevulinic acid hydrochloride via oral administration (20 mg/kg) 6-8 hours before CV01 treatment. |
| DEVICE | CV01 | Ultrasound will be delivered 6-8 hours after administration of 5-aminolevulinic acid hydrochloride. A total of 12 fields will be treated (10 treatment sites across the hemisphere with 2 additional treatments over areas of increased enhancement). |
Timeline
- Start date
- 2025-01-27
- Primary completion
- 2026-02-09
- Completion
- 2026-02-09
- First posted
- 2024-10-30
- Last updated
- 2026-02-27
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06665724. Inclusion in this directory is not an endorsement.