Testing an Ultrasound Device With a Study Drug for Newly Diagnosed Glioblastoma
Original title: Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
How far along is this research?
This is a trial that is enrolling or has been updated. It is not a finding yet.
This is a middle stage trial, so the treatment is still being tested in people.
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on . Always check the trial page for the latest.
The short version
This trial is testing whether a study drug plus a non-invasive ultrasound device can help people with newly diagnosed glioblastoma: A glioma that is given grade 4. Grade 4 is the highest grade there is. The tumor grows fast. Treatment usually starts soon after it is found. It often means surgery, and then radiation and chemotherapy. See the glossary after their usual treatment.
Who this trial is for. This trial is for people with newly diagnosed glioblastoma: A glioma that is given grade 4. Grade 4 is the highest grade there is. The tumor grows fast. Treatment usually starts soon after it is found. It often means surgery, and then radiation and chemotherapy. See the glossary who have already had standard care, meaning surgery and chemoradiation: Radiation and chemotherapy over the same weeks. They are given together. Not one after the other. It is the usual plan for glioblastoma, IDH-wildtype. Some other tumors get the two apart. What you get depends on your tumor type. See the glossary. It tests an investigational drug called 5-ALA: A medicine you are given before some brain operations. The tumor soaks it up. Under a special light the tumor then glows, so the surgeon can see where it stops and healthy brain starts. See the glossary together with a non-invasive ultrasound device called LIDU, which is meant to target tumor cells.
Where it stands. There are no results yet. People who join are put by chance into one of two groups. One group gets the study drug and active ultrasound. The other group gets a placebo drug and ultrasound that is not turned on. Neither the patient nor the doctor knows which group a person is in. Both groups keep taking their oral temozolomide: A chemotherapy taken as a capsule, used for some brain tumors. Your team checks your blood counts while you are on it. See the glossary. The trial is looking at whether the study drug and device are useful in treating glioblastoma: A glioma that is given grade 4. Grade 4 is the highest grade there is. The tumor grows fast. Treatment usually starts soon after it is found. It often means surgery, and then radiation and chemotherapy. See the glossary. That answer is not in yet.
What this means, and what it doesn't
What it could mean: If you have newly diagnosed glioblastoma: A glioma that is given grade 4. Grade 4 is the highest grade there is. The tumor grows fast. Treatment usually starts soon after it is found. It often means surgery, and then radiation and chemotherapy. See the glossary and have finished surgery and chemoradiation: Radiation and chemotherapy over the same weeks. They are given together. Not one after the other. It is the usual plan for glioblastoma, IDH-wildtype. Some other tumors get the two apart. What you get depends on your tumor type. See the glossary, this is one option you could ask your care team about. They can tell you if it makes sense for your situation.
What it doesn't mean: This does not mean the treatment works. A trial is a test, not a proven treatment. Joining one is not a guarantee that you will benefit. Some people in this trial get a placebo and ultrasound that is not turned on. This is not a promise of a cure.
Source: ClinicalTrials.gov, July 17, 2026 · Read the original
This plain-language summary was written by AI and published automatically after passing our automatic safety checks. How we write.