tFUS Brain Imaging for Brain Cancer

Overseen By David Darrow, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Awake craniotomy, Unhealed wounds, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to image and treat brain cancer using transcranial focused ultrasound (tFUS). This technique may provide a cheaper and faster alternative to traditional MRI scans. It also evaluates how effectively tFUS can assist in treatments such as adjusting nerve activity, opening the blood-brain barrier, and destroying tumor tissue without surgery. It suits individuals scheduled for brain surgery who meet specific medical criteria. As an unphased trial, this study allows patients to contribute to groundbreaking research that could revolutionize brain cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcranial focused ultrasound (tFUS) is safe for brain imaging?

Research shows that transcranial focused ultrasound (tFUS) is a non-invasive method that might be safe for humans. Studies have found that tFUS can target specific parts of the brain without surgery, eliminating the need for cuts and typically reducing risk.

Some studies have shown that tFUS can be used safely for brain treatments without general anesthesia, suggesting the procedure might be manageable. However, other research indicates that the safety and effectiveness of tFUS, especially for treating brain tumors, remain under investigation. While promising signs exist, more research is needed to understand all possible risks.

In summary, tFUS appears to be a safe and non-invasive method so far, but ongoing studies aim to confirm its safety and effectiveness for brain treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Focused Ultrasound (tFUS) is unique because it offers a non-invasive approach to brain cancer treatment, unlike traditional methods like surgery, radiation, or chemotherapy. This technique uses sound waves to target and disrupt cancerous tissues without needing to open the skull, reducing the risks and recovery time associated with invasive procedures. Researchers are excited about tFUS because it may allow for precise targeting of tumors with minimal impact on surrounding healthy brain tissue, potentially leading to fewer side effects and improved patient outcomes.

What evidence suggests that transcranial focused ultrasound is effective for brain cancer?

Research shows that transcranial focused ultrasound (tFUS), which participants in this trial will receive, could be a promising treatment for brain conditions. Studies have found that high-intensity focused ultrasound (HIFU) can safely destroy brain tumors by working through the skin after a small opening is made in the skull. Early results suggest that tFUS might reduce the need for invasive brain tumor biopsies and help monitor glioblastoma treatment. This method offers a non-invasive way to image and treat the brain by using ultrasound to target specific areas. While more research is needed, these early findings are encouraging for brain cancer treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults who are scheduled for brain surgery, can give informed consent, and will be under general anesthesia. They must have detailed contrast imaging of the brain available and use neuronavigation during surgery. It's not for those with scalp wounds/infections, significant health risks as judged by the lead researcher, or pregnant individuals.

Inclusion Criteria

I am scheduled for surgery under general anesthesia.

My surgery will use advanced GPS-like technology.

Able to undergo informed consent

Exclusion Criteria

I don't have heart or lung problems that make surgery risky.

I have open wounds or infections on my scalp.

I am scheduled for a surgery on my brain while I am awake.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline imaging and segmentation using ultrasound and MRI to assess feasibility and volume

1 week

1 visit (in-person)

Intraoperative Imaging

Noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Focused Ultrasound

Trial Overview The study tests if transcranial focused ultrasound (tFUS) can effectively target and image brain tumors compared to MRI. tFUS may offer a cheaper alternative with better time resolution without invasive procedures like neuromodulation or thermal ablation that MRI-guided treatments require.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

Participants scheduled for brain surgery

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Transcranial focused ultrasound (tFUS) is a promising non-surgical technique for neuromodulation that offers better spatial resolution compared to traditional electro and electromagnetic methods.

tFUS can effectively target sub-cortical brain structures non-invasively, and its combination with BOLD functional MRI allows for enhanced examination of brain activity in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound for BOLD fMRI signal modulation in humans. Leo Ai, ., Mueller, JK., Grant, A., et al.[2022]

Transcranial focused ultrasound (tFUS) can selectively target and modulate deep brain structures, such as the amygdala and entorhinal cortex, in healthy adults, leading to significant changes in brain perfusion and activity.

The study demonstrated that tFUS does not activate the auditory cortex, indicating that its effects are due to direct neuromodulation rather than an acoustic response, suggesting potential therapeutic applications for neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound selectively increases perfusion and modulates functional connectivity of deep brain regions in humans. Kuhn, T., Spivak, NM., Dang, BH., et al.[2023]

MRI-guided high-intensity focused ultrasound (MRIgFUS) shows promise as an effective method for thermocoagulating recurrent glioblastoma multiforme, as demonstrated in a Phase I study involving three patients.

While MRIgFUS can successfully destroy tumor tissue, there is a risk of neurological deficits due to unintended heating of surrounding brain tissue, prompting the development of software modifications to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided, high-intensity focused ultrasound for brain tumor therapy. Ram, Z., Cohen, ZR., Harnof, S., et al.[2006]

The dual-channel radiofrequency receive-only head coil significantly improves imaging quality in tcMRgFUS, providing up to 4 times better signal-to-noise ratio (SNR) compared to the standard body coil, which enhances visualization of critical brain structures.

The head coil also improves MR thermometry accuracy, reducing temperature uncertainty from 0.96°C to 0.41°C, allowing for more precise monitoring of thermal ablation during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an MRI receive head coil for use in transcranial MR guided focused ultrasound for functional neurosurgery. Bitton, RR., Sheingaouz, E., Assif, B., et al.[2021]

Magnetic resonance guided focused ultrasound (MRgFUS) has been FDA approved for treating essential tremor that doesn't respond to other treatments, highlighting its safety and efficacy as a new intervention.

The article discusses optimization strategies for imaging before, during, and after the procedure, emphasizing the importance of effective MRI techniques to ensure successful ablation during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranial MR-guided Focused Ultrasound for Essential Tremor : Technical Considerations and Image Guidance. Levi Chazen, J., Stradford, T., Kaplitt, MG.[2020]

Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technique that can precisely target and treat brain disorders by creating thermal lesions and disrupting the blood-brain barrier, which is a significant advancement in neurotherapeutics.

MRgFUS has been successfully used in various clinical applications, including treating bone metastases and uterine fibroids, and is being explored as a safer alternative to traditional neurosurgery for a range of brain-related conditions, supported by studies from small animal models to large clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial applications of magnetic resonance-guided focused ultrasound. Lipsman, N., Mainprize, TG., Schwartz, ML., et al.[2021]

Transcranial focused ultrasound (tFUS) can be effectively planned using synthesized CT (sCT) images generated from MRI, which avoids the need for potentially harmful CT radiation, showing high correlation with real CT (rCT) images in skull measurements.

The study demonstrated that the differences in simulated peak pressure and focal locations between sCT and rCT were minimal, indicating that sCT can be a reliable alternative for tFUS treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of synthetically generated computed tomography for use in transcranial focused ultrasound procedures. Liu, H., Sigona, MK., Manuel, TJ., et al.[2023]

Magnetic resonance-guided focused ultrasound (MRgFUS) has been shown to effectively and safely disrupt the blood-brain barrier (BBB), enhancing the delivery of various chemotherapeutic agents into brain tumors, as evidenced by preclinical studies and initial clinical trials.

The use of MRgFUS in glioma patients has demonstrated improved penetration of drugs like gadolinium across the BBB, indicating its potential to improve treatment outcomes, although further research is needed to fully understand drug distribution and effects on tumor growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Ultrasound Strategies for Brain Tumor Therapy. Bunevicius, A., McDannold, NJ., Golby, AJ.[2022]

A 63-year-old patient with a recurrent glioblastoma underwent transcranial MR-guided focused ultrasound surgery (MRgFUS), demonstrating the feasibility of this noninvasive technique for brain tumor ablation.

The procedure involved 25 high-power sonications and successfully achieved partial tumor ablation without causing neurological deficits or adverse effects, highlighting its safety and potential for treating brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First noninvasive thermal ablation of a brain tumor with MR-guided focused ultrasound. Coluccia, D., Fandino, J., Schwyzer, L., et al.[2020]

MR-guided focused ultrasound (MRgFUS) is a promising non-invasive technique for treating deep brain conditions, showing effectiveness in chronic diseases like Parkinson's and essential tremor, as well as in neuropathic pain.

The method is advantageous because it does not require anesthesia, avoids ionizing radiation, and has low complication rates, making it a safer alternative to traditional neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided focused ultrasound: a new generation treatment of Parkinson's disease, essential tremor and neuropathic pain. Dobrakowski, PP., Machowska-Majchrzak, AK., Labuz-Roszak, B., et al.[2021]

Transcranial MRI-guided focused ultrasound (MRgFUS) is an established therapy for treating essential and parkinsonian tremors, showing long-term safety and efficacy in recent studies.

The technique is expanding beyond tremors to include new indications like focal dystonia and neuropsychiatric conditions, with promising preliminary results, and it also allows for innovative applications such as opening the blood-brain barrier and neuromodulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update in the clinical application of focused ultrasound. Natera-Villalba, E., Matarazzo, M., Martinez-Fernandez, R.[2022]

A systematic review of 33 studies on low-intensity transcranial focused ultrasound stimulation (TFUS) indicates that adverse effects are very rare, with most studies showing no significant negative outcomes even when safety limits were exceeded.

However, at high stimulation intensities, TFUS can potentially cause serious issues like hemorrhage, cell death, and unintended blood-brain barrier opening, highlighting the need for further research to establish clear safety guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial focused ultrasound stimulation: A systematic review of the state of knowledge from both human and animal studies. Pasquinelli, C., Hanson, LG., Siebner, HR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5907801/

Magnetic resonance–guided interstitial high-intensity ... We propose a system that utilizes an intraparenchymal catheter to deliver HIFU therapy to treat intracranial neoplasms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4068031/

High intensity focused ultrasound surgery (HIFU) of the brain The high-intensity ultrasound was found safe for the destruction of brain tumors.(21) These treatments were performed after a craniectomy, through the skin, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05755399

Feasibility of Transcranial Focused Ultrasound to Measure ... Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950162824000183

Magnetic resonance-guided focused ultrasound in ... In this article, we summarize clinical trials of high-intensity FUS in the treatment of intracranial diseases. Next, we introduce the preclinical and clinical ...

5. fusfoundation.org fusfoundation.org/the-technology/timeline-of-focused-ultrasound/

Timeline of Focused Ultrasound The results suggest that focused ultrasound could reduce the need for invasive brain tumor biopsies and allow better monitoring of glioblastoma treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2939497/

Transcranial MRI-guided focused ultrasound surgery of brain ... We found that it was possible to focus an ultrasound beam transcranially into the brain and to visualize the heating with MR temperature imaging.

7. fusfoundation.org fusfoundation.org/for-researchers-and-clinicians/foundation-funded-research-projects/

Foundation Funded Research Projects Will FUS be safe and effective in treating patients with brain tumors? A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused ...

8. nature.com nature.com/articles/s41380-025-03033-w

Low-intensity transcranial focused ultrasound amygdala ... tFUS is a non-invasive technique for direct subcortical neuromodulation, but its safety, feasibility, and promise as a potential treatment is largely unknown.

9. ashpublications.org ashpublications.org/blood/article/144/10/1101/516866/Low-intensity-transcranial-focused-ultrasound

Low-intensity transcranial focused ultrasound suppresses ... We demonstrate that tFUS stimulation at pain-processing brain circuits can significantly alter pain-associated behaviors in mouse models in vivo ...