NCT07405645

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
45mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Dec 2029

First Submitted

Initial submission to the registry

January 22, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 22, 2026

Last Update Submit

February 4, 2026

Conditions

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

Keywords

cancer painmesencephalotomyfocused ultrasound

Outcome Measures

Primary Outcomes (2)

  • Primary Safety Outcome

    Safety as assessed from adverse event reporting.

    Intervention through 6 months

  • Primary Efficacy Outcome

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

    24 hours before (baseline) and at 3 months following unilateral FUS mesencephalotomy

Secondary Outcomes (1)

  • Secondary Outcomes

    baseline to 3 months post-treatment

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

Single Group Assignment

Device: ExAblate Neuro

Interventions

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.

Single Group Assignment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

NOT YET RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77054, United States

NOT YET RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William J Elias, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William J Elias, MD

CONTACT

434-924-0451wje4r@uvahealth.org

Marian Abdelmalek, MS

CONTACT

434-924-8827mka6s@uvahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurological Surgery

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 12, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

February 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)