Focused Ultrasound for Low Grade Glioma

Overseen By Barshen Habelhah

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Mild cognitive impairment, Moderate dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 hour

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests focused ultrasound as a new treatment for low-grade gliomas, which are slow-growing brain tumors. The researchers aim to determine if this non-invasive technique can be effective, particularly for patients requiring ongoing treatment. Ideal participants regularly undergo MRI scans for their low-grade gliomas. While there is no direct benefit to joining the trial, participation could aid others with similar conditions in the future. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future treatments for low-grade gliomas.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that focused ultrasound is safe for treating low grade glioma?

Research has shown that focused ultrasound is generally safe for humans. Safety tests have demonstrated that this method can maintain a specific temperature without harming tissues. In some studies, patients experienced no tissue damage after treatment. Other research highlights that the main goals of focused ultrasound trials are to ensure safety and comfort, with close monitoring for any side effects or issues. While research continues, these findings suggest that focused ultrasound is being carefully studied for safety in treating brain conditions like low-grade gliomas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about focused ultrasound for treating low-grade glioma because it offers a non-invasive alternative to surgery or radiation. Unlike traditional treatments that might involve cutting into the brain or exposing it to radiation, focused ultrasound uses sound waves to target and disrupt tumor cells without harming surrounding healthy tissue. This method could potentially reduce recovery time and minimize side effects, making it a promising option for patients with this type of brain tumor.

What evidence suggests that focused ultrasound is effective for low grade glioma?

Research has shown that focused ultrasound, the treatment under study in this trial, could be a promising approach for low-grade gliomas, a type of brain tumor. Studies have found that it can safely open the blood-brain barrier, allowing chemotherapy to reach the brain more effectively. This enables more medicine to reach the tumor, potentially enhancing the treatment's effectiveness. Focused ultrasound is noninvasive, requiring no surgery and generally being easy for patients to tolerate. Although more research is needed, early results suggest it might improve treatment for people with gliomas. ^{1 3 6 7 8}

Who Is on the Research Team?

Sheldon Jordan, M.D.

Principal Investigator

Neurologist, NAOWLA

Are You a Good Fit for This Trial?

This trial is for adults over 18 with low grade gliomas who are already getting regular MRI scans. It's not for those with cognitive decline from mild to moderate dementia.

Inclusion Criteria

I regularly get MRI scans to monitor my low grade brain tumor.

Exclusion Criteria

I have mild to moderate memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo focused ultrasound treatment to evaluate the permeability of the blood-brain barrier

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event reporting and fMRI scans

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Focused Ultrasound

Trial Overview The study tests the use of focused ultrasound on the brain. The goal is to see if it can safely make the blood-brain barrier more permeable, potentially helping treat brain conditions less invasively.

How Is the Trial Designed?

Group I: Focused Ultrasound Experimental Treatment 1 Intervention

The ultrasound treatment will last either 1 hour or 20 minutes total time for the DWL device or Brainsonix Focused Ultrasound Device, respectively.

Focused Ultrasound is already approved in United States, European Union for the following indications:

Approved in United States as Gemzar for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer

Approved in European Union as Gemzar for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Published Research Related to This Trial

Low-intensity MR-guided focused ultrasound combined with microbubbles shows promise for safely delivering drugs to the central nervous system by temporarily opening the blood-brain barrier, which is crucial for treating brain cancers.

Preclinical studies have demonstrated the safety and preliminary efficacy of this method in animal models, suggesting it could be a noninvasive and repeatable approach for targeting drug delivery in neuro-oncology patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity MR-Guided Focused Ultrasound Mediated Disruption of the Blood-Brain Barrier for Intracranial Metastatic Diseases. Meng, Y., Suppiah, S., Surendrakumar, S., et al.[2020]

Transcranial microbubble-enhanced focused ultrasound (MB-FUS) safely and effectively opens the blood-brain barrier (BBB) in patients with infiltrating gliomas, as demonstrated in a Phase 0 clinical trial with MRI and histopathology confirming reproducible results.

The study found a significant increase in drug accumulation in treated tumor tissues, with a 2.2-fold increase in fluorescein compared to untreated areas, suggesting that MB-FUS could enhance the delivery of therapeutics for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized blood-brain barrier opening in infiltrating gliomas with MRI-guided acoustic emissions-controlled focused ultrasound. Anastasiadis, P., Gandhi, D., Guo, Y., et al.[2022]

In a phase I study involving 5 patients with high-grade glioma, MR-guided focused ultrasound (MRgFUS) was successfully used to temporarily open the blood-brain barrier (BBB) without surgery, allowing for enhanced delivery of chemotherapy.

The procedure was safe and well-tolerated, showing no adverse effects, and resulted in a significant increase in chemotherapy delivery to the targeted brain tissue, indicating its potential for improving treatment efficacy in brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study. Mainprize, T., Lipsman, N., Huang, Y., et al.[2020]

Diffuse Midline Glioma (DMG), previously known as Diffuse Intrinsic Pontine Glioma (DIPG), is a challenging pediatric brain tumor with no curative treatments available despite over 250 clinical trials.

Focused Ultrasound (FUS) is a promising noninvasive technology that can temporarily disrupt the blood-brain barrier, potentially allowing for better delivery of therapies and enhancing the effectiveness of treatments like chemotherapy and radiation for DMG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Past, present and future of Focused Ultrasound as an adjunct or complement to DIPG/DMG therapy: A consensus of the 2021 FUSF DIPG meeting. Parekh, K., LeBlang, S., Nazarian, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11135048/

Focused ultrasound as a treatment modality for gliomas - PMC This mini-review highlights the current knowledge surrounding using FUS as a treatment modality for gliomas.

2. thejns.org thejns.org/view/journals/j-neurosurg/142/6/article-p1635.xml

Focused ultrasound therapy as a strategy for improving glioma ... The study demonstrated successful BBB disruption in all 5 patients, with greater drug concentrations in brain regions with BBB disruption ...

3. fusfoundation.org fusfoundation.org/diseases-and-conditions/glioblastoma/

Glioblastoma Focused ultrasound is a noninvasive therapy that is transforming the treatment and quality of life for patients with glioblastoma.

4. withpower.com withpower.com/trial/focused-ultrasound-for-low-grade-glioma-0a608

Focused Ultrasound for Low Grade Glioma The procedure was safe and well-tolerated, showing no adverse effects, and resulted in a significant increase in chemotherapy delivery to the targeted brain ...

5. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/focused-ultrasound-for-high-grade-gliomas

Researchers Identify Key Metric in Delivering Focused ... Results published in Device identify a key metric—known as acoustic emission dose—which can predict how well the BBB opened, identifying a sweet ...

6. fusfoundation.org fusfoundation.org/diseases-and-conditions/brain-tumors/

Brain Tumors This study used oral gleolan (5 ALA) which becomes altered in the presence of focused ultrasound and becomes locally toxic to the tumor. A study ...

7. mdpi.com mdpi.com/2076-3417/15/21/11322

Focused Ultrasound (FUS) and Pediatric Brain Tumors Safety experiments showed that hyperthermia at 41.5 ± 0.5 °C for 10 min could be maintained consistently without tissue injury. Using this data, the group ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10260092/

SURG-02. MAGNETIC RESONANCE-GUIDED HIGH ... SURG-02. MAGNETIC RESONANCE-GUIDED HIGH-INTENSITY FOCUSED ULTRASOUND (MRGHIFU) FOR TREATMENT OF LOW GRADE GLIOMA IN A PEDIATRIC PATIENT.