Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Virginia
Study ID
NCT07405645
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • ExAblate Neuro — DEVICE
    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 Details

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.

Key Dates

Start date
Feb 15, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Single Group Assignment
    Single Group Assignment

Primary Outcome Measure

Primary Safety Outcome [ Time Frame: Intervention through 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Garth Cosgrove, MD
617-732-6858
Rees Cosgrove, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Michael Kaplitt, MD
646-962-8169
Michael Kaplitt, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Michael McGahee
971-509-4932
Ahmed Raslan, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Southwestern Medical CenterDallasTexas75390
Tash Mupambo
214-645-1355
Nader Pouratian, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77054
Ashwin Viswanathan, MD
713-798-4696
Ashwin Viswanathan, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Jeffrey Elias, MD
434-924-0451
Zachary Sturgill
434-243-9986

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