tFUS Brain Imaging for Brain Cancer

Recruiting in Palo Alto (17 mi)

Overseen by David Darrow, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

Disqualifiers: Awake craniotomy, Unhealed wounds, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. Compared with the gold- standard for brain imaging, magnetic resonance imaging (MRI), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. In addition, while MRI is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused ultrasound (HIFU). All three treatment options require targeting therapy through the skull, which remains a barrier to clinical translation. This proposal is to test the feasibility of acquiring noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery. By acquiring volumetric ultrasound images while coregistered to previously obtained stereotactic magnetic resonance imaging, the study will be able to compare the ability of tFUS to identify and focus on brain pathology.

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 data supports the effectiveness of the treatment Transcranial Focused Ultrasound (tFUS) for brain cancer?

Research shows that Magnetic Resonance Guided Focused Ultrasound (MRgFUS) is a promising tool for treating brain tumors by enhancing the delivery of chemotherapy and precisely targeting and destroying tumor tissue. It has been used successfully for other conditions like essential tremor and is being explored for brain cancer treatment. ^{1 2 3 4 5}

Is transcranial focused ultrasound safe for humans?

Research shows that transcranial focused ultrasound (tFUS) has been used safely in humans for various conditions, including brain tumors and neurological disorders like Parkinson's disease and essential tremor. Studies have reported successful procedures without causing neurological deficits or other adverse effects, suggesting it is generally safe. ^{6 7 8 9 10}

How does the tFUS treatment for brain cancer differ from other treatments?

The tFUS (transcranial focused ultrasound) treatment is unique because it can non-invasively target deep brain structures using sound waves, unlike traditional treatments that may require surgery or radiation. This method allows for precise targeting of brain areas without the need for incisions or exposure to harmful radiation. ^{1 2 8 11 12}

Eligibility Criteria

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

Able to undergo informed consent

Thin cut post-contrast imaging available for coregistration

I am scheduled for and will attend brain surgery.

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.

Trial Timeline

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

Treatment Details

Interventions

• Transcranial Focused Ultrasound (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.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Participants scheduled for brain surgery

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Minnesota Minneapolis, MN

Who Is Running the Clinical Trial?

University of Minnesota Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Update in the clinical application of focused ultrasound. [2022] To review the most recent evidence about the clinical applicability of transcranial MRI-guided focused ultrasound (MRgFUS), including clinical evidence and indications, recent technical developments for its use and future prospects.

2. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided, high-intensity focused ultrasound for brain tumor therapy. [2006] Magnetic resonance imaging-guided high-intensity focused ultrasound (MRIgFUS) is a novel technique that may have the potential for precise image-guided thermocoagulation of intracranial lesions. The system delivers small volumetric sonications from an ultrasound phased array transmitter that focuses energy selectively to destroy the target with verification by magnetic resonance imaging-generated thermal maps. A Phase I clinical study was initiated to treat patients with recurrent glioma with MRIgFUS.

3. United States pubmed.ncbi.nlm.nih.gov

Focused Ultrasound Strategies for Brain Tumor Therapy. [2022] A key challenge in the medical treatment of brain tumors is the limited penetration of most chemotherapeutic agents across the blood-brain barrier (BBB) into the tumor and the infiltrative margin around the tumor. Magnetic resonance-guided focused ultrasound (MRgFUS) is a promising tool to enhance the delivery of chemotherapeutic agents into brain tumors.

4. Germany pubmed.ncbi.nlm.nih.gov

Cranial MR-guided Focused Ultrasound for Essential Tremor : Technical Considerations and Image Guidance. [2020] Magnetic resonance guided focused ultrasound (MRgFUS) recently received FDA approval for treatment of medically refractory essential tremor and significant progress continues to be made in operational protocols. To that end, the goal of this technical article is to illustrate current optimization strategies for preprocedural, intraprocedural, and postprocedural imaging, with a particular focus on technically challenging intraprocedural MRI to assess satisfactory ablation.

5. United States pubmed.ncbi.nlm.nih.gov

Intracranial applications of magnetic resonance-guided focused ultrasound. [2021] The ability to focus acoustic energy through the intact skull on to targets millimeters in size represents an important milestone in the development of neurotherapeutics. Magnetic resonance-guided focused ultrasound (MRgFUS) is a novel, noninvasive method, which--under real-time imaging and thermographic guidance--can be used to generate focal intracranial thermal ablative lesions and disrupt the blood-brain barrier. An established treatment for bone metastases, uterine fibroids, and breast lesions, MRgFUS has now been proposed as an alternative to open neurosurgical procedures for a wide variety of indications. Studies investigating intracranial MRgFUS range from small animal preclinical experiments to large, late-phase randomized trials that span the clinical spectrum from movement disorders, to vascular, oncologic, and psychiatric applications. We review the principles of MRgFUS and its use for brain-based disorders, and outline future directions for this promising technology.

6. United States 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. [2020] Low-intensity transcranial focused ultrasound stimulation (TFUS) holds great promise as a highly focal technique for transcranial stimulation even for deep brain areas. Yet, knowledge about the safety of this novel technique is still limited.

7. England pubmed.ncbi.nlm.nih.gov

First noninvasive thermal ablation of a brain tumor with MR-guided focused ultrasound. [2020] Magnetic resonance-guided focused ultrasound surgery (MRgFUS) allows for precise thermal ablation of target tissues. While this emerging modality is increasingly used for the treatment of various types of extracranial soft tissue tumors, it has only recently been acknowledged as a modality for noninvasive neurosurgery. MRgFUS has been particularly successful for functional neurosurgery, whereas its clinical application for tumor neurosurgery has been delayed for various technical and procedural reasons. Here, we report the case of a 63-year-old patient presenting with a centrally located recurrent glioblastoma who was included in our ongoing clinical phase I study aimed at evaluating the feasibility and safety of transcranial MRgFUS for brain tumor ablation. Applying 25 high-power sonications under MR imaging guidance, partial tumor ablation could be achieved without provoking neurological deficits or other adverse effects in the patient. This proves, for the first time, the feasibility of using transcranial MR-guided focused ultrasound to safely ablate substantial volumes of brain tumor tissue.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound selectively increases perfusion and modulates functional connectivity of deep brain regions in humans. [2023] Low intensity, transcranial focused ultrasound (tFUS) is a re-emerging brain stimulation technique with the unique capability of reaching deep brain structures non-invasively.

9. United States pubmed.ncbi.nlm.nih.gov

MR-guided focused ultrasound: a new generation treatment of Parkinson's disease, essential tremor and neuropathic pain. [2021] The application of high intense focused ultrasound (HIFU) is currently the subject of many experimental and clinical trials. The combination of HIFU with MRI guidance known as MR-guided focused ultrasound (MRgFUS) appears to be particularly promising to ablate tissues located deep in the brain. The method can be the beginning of interventional neurology and an important alternative to neurosurgery. Studies conducted to date show the effectiveness of the method both in chronic diseases and in emergency cases. The safety and effectiveness of this method have been observed in parkinsonian and essential tremor as well as in neuropathic pain. The procedure does not require anaesthesia. Ionizing radiation is not used and there is no risk of cumulative dose. Such advantages may result in low complication rates and medical justification for further development of MRgFUS.

10. United States pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound for BOLD fMRI signal modulation in humans. [2022] Transcranial focused ultrasound (tFUS) is an emerging form of non-surgical human neuromodulation that confers advantages over existing electro and electromagnetic technologies by providing a superior spatial resolution on the millimeter scale as well as the capability to target sub-cortical structures non-invasively. An examination of the pairing of tFUS and blood oxygen level dependent (BOLD) functional MRI (fMRI) in humans is presented here.

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of synthetically generated computed tomography for use in transcranial focused ultrasound procedures. [2023] Transcranial focused ultrasound (tFUS) is a therapeutic ultrasound method that focuses sound through the skull to a small region noninvasively and often under magnetic resonance imaging (MRI) guidance. CT imaging is used to estimate the acoustic properties that vary between individual skulls to enable effective focusing during tFUS procedures, exposing patients to potentially harmful radiation. A method to estimate acoustic parameters in the skull without the need for CT is desirable.

12. England pubmed.ncbi.nlm.nih.gov

Evaluation of an MRI receive head coil for use in transcranial MR guided focused ultrasound for functional neurosurgery. [2021] Trans-cranial MR guided focused ultrasound (tcMRgFUS) ablation targets are