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Focused Ultrasound for Head and Neck Cancer Pain

This study is testing a new way to treat severe, ongoing pain from head and neck cancer or brachial cancer (cancer in the arm/shoulder area) that hasn't responded to other pain medications. It uses a device called ExAblate Neuro, which delivers focused ultrasound waves to a specific area deep in the brain (mesencephalon) without needing any cuts or implants. This treatment is guided by MRI (Magnetic Resonance Imaging) for accuracy. The study aims to see how safe this treatment is and how well it reduces pain. You might be able to join if you are between 18 and 85 years old and have head, neck, or brachial cancer with severe, opioid-resistant pain. The study plans to enroll 20 participants.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage study to test safety and initial effectiveness. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the time of the intervention through 6 months. Pain relief will be measured at 3 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07405645

Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy

Recruiting
NAAges 18–85InterventionalSupportive care
University of Virginia
~20 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:ExAblate Neuro

At a glance

Recruiting sites
1 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Outcome
Measured over Intervention through 6 months
+1 more outcome measured

Conditions

Head Neck Cancer
Squamous Cell Cancer of Head and Neck (SCCHN)
Cancer Pain

Explore related trials

Brachial CancerLymphomaMalignant Head and Neck NeoplasmSarcoma

Where it's being run

6 sites across 5 states
Texas2
Massachusetts1
New York1
Oregon1
Virginia1

Study leadership

  • William J Elias, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

William J Elias, MD
[email protected]
434-924-0451
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cancer that arises in the head and neck region: nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx (typically squamous cell carcinoma)
Cancer occurring in the nasopharynx, skin, thyroid gland, and eye
Cancer involving the brachial region including brachial plexus, upper lung apex, and Pancoast tumors.
Lymphoma
Sarcoma 3. Craniofacial, cervical, or brachial pain related to the cancer that meets all of the following criteria:
Severe defined by: Worst NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months.
Pain is medication-refractory to all three tiers of the WHO cancer pain ladder. Thus, adequate trials of at least 3 prescription medications that will include a 'weak' and a 'strong' opioid. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
Duration of greater than 3 months. 4. Mesencephalon contralateral to the pain can be targeted by the ExAblate Neuro device. The region of the mesencephalon must be apparent on MRI. Additional MRI sequences including inversion-recovery and DTI may be utilized to refine the target. 5. Subjects who are able and willing to give consent and able to attend all study visits 6. Subjects who are able to communicate sensations during the focused ultrasound treatment

What this trial measures

  • Primary Safety OutcomeIntervention through 6 months

    Safety as assessed from adverse event reporting.

  • Primary Efficacy Outcome24 hours before (baseline) and at 3 months following unilateral FUS mesencephalotomy

    To compare the change of WORST pain experienced. 11-point Numeric Pain Rating Scale (NPRS)