Head Neck CancerMRg-FUSNCT07405645
Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy
A study testing ExAblate Neuro in people with Head Neck Cancer and Squamous Cell Cancer of Head and Neck (SCCHN), run by University of Virginia at 6 sites in United States.
Trial summary
This phase 1 multi-site study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer and brachial cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head Neck Cancer, Squamous Cell Cancer of Head and Neck (SCCHN), Cancer Pain
- What is being tested?
- ExAblate Neuro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between 18 and 85 years, inclusive
- Subjects with head, neck, or brachial cancer, including one of the following:
- 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
Show all 14Show fewer
- Sarcoma
- 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.
- 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.
- Subjects who are able and willing to give consent and able to attend all study visits
- Subjects who are able to communicate sensations during the focused ultrasound treatment
Who cannot join
- Idiopathic trigeminal neuralgia
- Trigeminal neuropathic pain from trauma, infection, or iatrogenic
- Post-herpetic neuralgia
- Headache syndromes like migraine, cluster headache
- Temporomandibular joint syndrome
- Atypical facial pain or pain related to a somatoform disorder
Show all 42Show fewer
- Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:
- Subject deemed by their oncologist to have limited life expectancy for outcome assessment. At least 3 months life expectancy is required to obtain the primary efficacy outcome measure.
- Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
- Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
- Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
- been hospitalized for the treatment of a psychiatric illness within the past 2 years
- received transcranial magnetic stimulation for depression treatment
- received electroconvulsive therapy for depression
- any presence or history of psychosis
- Subjects with unstable cardiac status including:
- Unstable angina pectoris on medication
- Subjects with documented myocardial infarction within six months of protocol entry
- Significant congestive heart failure defined with ejection fraction < 40
- Subjects with unstable ventricular arrhythmias
- Subjects with atrial arrhythmias that are not rate-controlled
- Severe hypertension (diastolic BP > 100 on medication)
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- On medications that increases the bleeding risk, based on the published guidelines which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and the North American Neuromodulation Society (Reg Anesth Pain Med 2015;40: 182-212); specifically:
- Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abiciximab) for the last 7 days prior to treatment.
- Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours.
- Intravenous or subcutaneous heparin-derived compounds for the last 48 hours.
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)
- Subjects participating or have participated in another pain management clinical trial in the last 30 days
- Subjects with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits.
- Subjects with brain tumors or any significant intracranial mass that impedes the acoustic beam. Subjects with cerebral metastasis may be included if the lesion(s) do not affect the FUS treatment.
- Any illness that in the investigator's opinion preclude participation in this study
- Pregnancy or lactation
- Legal incapacity or limited legal capacity
- Subjects with a deep brain stimulation implant
- Skull density ratio, calculated from the baseline noncontrasted head CT, is less than 0.4
- History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
- Subjects whose primary pain is other than craniofacial or brachial neuropathic pain.
- Patients deemed high risk because of their airway for the procedure as evaluated by anesthesia.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Garth Cosgrove, MD, 617-732-6858, rcosgrove2@bwh.harvard.edu
Rees Cosgrove, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Jeffrey Elias, MD, 434-924-0451, WJE4R@uvahealth.org
Zachary Sturgill, 434-243-9986, FFM7RC@uvahealth.org
- Not yet recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Tash Mupambo, 214-645-1355, Tashinga.Mupambo@UTSouthwestern.edu
Nader Pouratian, MD
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77054
Ashwin Viswanathan, MD, 713-798-4696, ashwinv@bcm.edu
Ashwin Viswanathan, MD
- Not yet recruiting
Weill Cornell Medicine
New York, New York, 10065
Michael Kaplitt, MD, 646-962-8169, mik2002@med.cornell.edu
Michael Kaplitt, MD
- Not yet recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Michael McGahee, 971-509-4932, mcgehee@ohsu.edu
Ahmed Raslan, MD
About this study
Official title: Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head, Neck, & Brachial Cancer
This phase 1 multi-site study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer and brachial cancer.
Read the detailed description
This phase 1 study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head, neck, and brachial cancer.
Safety: To evaluate the incidence and severity of adverse events associated with unilateral stereotactic focused ultrasound mesencephalotomy.
Efficacy: To determine the level or degree of pain relief in the head, neck, and brachial regions using validated numeric pain scales and patient-reported measures of pain.
The rationale for this proposed Phase 1 study is based upon:
- The pain associated with head, neck, and brachial cancer is one of the most severe and difficult conditions because it is:
- notoriously refractory to medical therapies,
- localized to the highest regions of the neural axis and is thus not amenable to traditional surgical options like intrathecal opioids or spinal cordotomy, and
- affects them during the terminal stages of life.
- Stereotactic mesencephalotomy, targeted to the confluence of the spinoreticular and spinothalamic tracts, has been associated with pain relief from malignancy, but historical stereotactic methods lacked precision to reduce morbidity for routine adoption.
- Focused ultrasound has been demonstrated to be a precise stereotactic lesioning modality, and the technique can be performed without incisions or craniotomy. Continuous closed-loop monitoring of the thermal ablation process with MRI has yielded lesion accuracies consistently < 1 millimeter.
- Being tested
- ExAblate Neuro
- Keywords
- cancer pain, mesencephalotomy, focused ultrasound
- Medical subject headings
- Head and Neck Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate NeuroDevice
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | Single Group Assignment Receives: Device: ExAblate Neuro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome
Safety as assessed from adverse event reporting.
Measured: Intervention through 6 months
Primary Efficacy Outcome
To compare the change of WORST pain experienced. 11-point Numeric Pain Rating Scale (NPRS)
Measured: 24 hours before (baseline) and at 3 months following unilateral FUS mesencephalotomy
Secondary outcomes (1)
Secondary Outcomes
Patient Global Impression of Change and the Pain Domain from the PROMIS Inventory including items for intensity, quality, behavior and interference.
Measured: baseline to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Neck CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Responsible party
- Principal investigator, Jeff Elias, MD, University of Virginia
- Investigators
- William J Elias, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405645
- Sponsor's protocol ID
- HSR180040-1
- Acronym
- MRg-FUS
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head, Neck, & Brachial Cancer
- ClinicalTrials.gov ID
- NCT07405645
- Acronym / sponsor ID
- MRg-FUS / HSR180040-1
- Keywords
- cancer pain, mesencephalotomy, focused ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1 multi-site study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer and brachial cancer.
Detailed description
This phase 1 study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head, neck, and brachial cancer.
Safety: To evaluate the incidence and severity of adverse events associated with unilateral stereotactic focused ultrasound mesencephalotomy.
Efficacy: To determine the level or degree of pain relief in the head, neck, and brachial regions using validated numeric pain scales and patient-reported measures of pain.
The rationale for this proposed Phase 1 study is based upon:
- The pain associated with head, neck, and brachial cancer is one of the most severe and difficult conditions because it is:
- notoriously refractory to medical therapies,
- localized to the highest regions of the neural axis and is thus not amenable to traditional surgical options like intrathecal opioids or spinal cordotomy, and
- affects them during the terminal stages of life.
- Stereotactic mesencephalotomy, targeted to the confluence of the spinoreticular and spinothalamic tracts, has been associated with pain relief from malignancy, but historical stereotactic methods lacked precision to reduce morbidity for routine adoption.
- Focused ultrasound has been demonstrated to be a precise stereotactic lesioning modality, and the technique can be performed without incisions or craniotomy. Continuous closed-loop monitoring of the thermal ablation process with MRI has yielded lesion accuracies consistently < 1 millimeter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Device: ExAblate NeuroSingle Group Assignment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women, between 18 and 85 years, inclusive
- Subjects with head, neck, or brachial cancer, including one of the following:
- Craniofacial, cervical, or brachial pain related to the cancer that meets all of the following criteria:
- 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.
- Subjects who are able and willing to give consent and able to attend all study visits
Key exclusion criteria (42 listed)
- Idiopathic trigeminal neuralgia
- Trigeminal neuropathic pain from trauma, infection, or iatrogenic
- Post-herpetic neuralgia
- Headache syndromes like migraine, cluster headache
- Temporomandibular joint syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate NeuroExablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. | Device | Single Group Assignment |
Primary outcome
Primary Safety Outcome
Time frame: Intervention through 6 months
Safety as assessed from adverse event reporting.
Primary Efficacy Outcome
Time frame: 24 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)
1 secondary outcome
Secondary Outcomes
Time frame: baseline to 3 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William J Elias, MD principal investigator
University of Virginia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate Neuro in people with Head Neck Cancer and Squamous Cell Cancer of Head and Neck (SCCHN), run by University of Virginia at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William J Elias, MD (434-924-0451, wje4r@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome (time frame: Intervention through 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.