Focused Ultrasound for Cancer-Associated Pain

(MRg-FUS Trial)

Recruiting at 5 trial locations

Overseen By Marian Abdelmalek, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Trigeminal neuralgia, Headache syndromes, Psychiatric illness, Cardiac issues, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and early effectiveness of a new treatment using focused ultrasound to reduce severe pain from head, neck, or brachial cancer. The treatment, called Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy, targets the brain area opposite the pain, offering hope for those who can't find relief with regular pain medications, including opioids. Ideal participants have experienced severe cancer-related pain for at least three months and have found no relief from multiple pain medications. As an unphased trial, this study provides a unique opportunity for patients to explore innovative pain relief options.

Will I have to stop taking my current medications?

The trial requires stopping certain medications that increase bleeding risk, like aspirin and anticoagulants, for a specific period before treatment. If you're on these medications, you'll need to stop them 48 to 72 hours before the procedure, depending on the type.

What prior data suggests that this focused ultrasound technique is safe for treating cancer-associated pain?

Research shows that a new treatment called focused ultrasound is under study for its safety in treating severe cancer pain. Earlier studies primarily focused on safety, assessing how well participants tolerated the treatment. For instance, one study found that most participants tolerated it well, with some side effects that were not serious.

Another study found that the treatment reduced pain without causing major issues, as most participants did not experience serious side effects. These results suggest that the treatment might be safe for those with cancer-related pain. However, this treatment remains under investigation, and further studies are necessary to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy because it offers a non-invasive alternative for managing cancer-associated pain. Unlike traditional pain management options, which often involve medications like opioids or invasive surgical procedures, this technique uses precisely focused ultrasound waves to target specific areas in the brain associated with pain processing. This method may provide pain relief without the side effects of drugs or the risks associated with surgery, making it an innovative option for patients seeking effective and less risky pain management solutions.

What evidence suggests that this focused ultrasound technique is effective for cancer-associated pain?

Research has shown that focused ultrasound on the mesencephalon can relieve severe pain. Participants in this trial will undergo Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy, which is being studied for its potential to reduce pain. Early experiences with this method showed pain reduction, but it wasn't widely adopted due to the risks of creating small, targeted injuries in the brain. Despite these concerns, initial studies suggest it might help those whose pain doesn't improve with opioids, particularly in cases of head, neck, and arm cancers. While more research is needed to confirm these findings, this method offers hope for those with limited pain relief options. ^{1 2 3 5 6}

Who Is on the Research Team?

William J Elias, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with severe, opioid-resistant pain due to head and neck cancers, including squamous cell carcinoma, lymphoma, sarcoma, and certain tumors. Eligible participants must have a mesencephalon visible on MRI that can be targeted by the ExAblate Neuro device and have experienced consistent severe pain for at least two months.

Inclusion Criteria

I am between 18 and 85 years old.

My cancer is in the head or neck area, like the throat or mouth.

My cancer is in the nasopharynx, skin, thyroid, or eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo focused ultrasound lesioning of the contralateral mesencephalon for pain palliation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy

Trial Overview

The study tests the safety and initial effectiveness of using focused ultrasound (ExAblate Neuro) to target the brain's mesencephalon region in order to alleviate severe cancer-associated pain that hasn't responded to strong opioids.

How Is the Trial Designed?

Group I: Single Group Assignment Experimental Treatment 1 Intervention

Single Group Assignment

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Focused Ultrasound Foundation

Collaborator

Trials

18

Recruited

460+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07405645

Stereotactic MRI-guided Focused Ultrasound ...

This phase 1 study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12406951/

Stereotactic Focused Ultrasound Mesencephalotomy for the ...

Early experiences relieved pain, but the procedure was never widely adopted because of the associated morbidity with midbrain lesioning.

3.

karger.com

karger.com/sfn/article-abstract/doi/10.1159/000547639/931042/Stereotactic-Focused-Ultrasound-Mesencephalotomy

Stereotactic Focused Ultrasound Mesencephalotomy for ...

Early experiences relieved pain, but the procedure was never widely adopted because of the associated morbidity with midbrain lesioning.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40716439/

Stereotactic Focused Ultrasound Mesencephalotomy for the ...

Early experiences relieved pain, but the procedure was never widely adopted because of the associated morbidity with midbrain lesioning.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03894553

Study Details | NCT03894553 | Focused Ultrasound (FUS) ...

This pilot study is designed as a prospective, open-label clinical trial of stereotactic FUS mesencephalotomy in 6 subjects with treatment-refractory pain ...

6.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-12740

Stereotactic MRI-Guided Focused Ultrasound ...

This study evaluates the safety and effects of the ExAblate Neuro when used for reducing pain related to head and neck cancer.