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.
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: 1. 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. 2. 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. 3. 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGWeill Cornell Medicine
New York, New York, United States
NOT_YET_RECRUITINGOregon Health and Science University
Portland, Oregon, United States
Primary Safety Outcome
Safety as assessed from adverse event reporting.
Time frame: Intervention through 6 months
Primary Efficacy Outcome
To compare the change of WORST pain experienced. 11-point Numeric Pain Rating Scale (NPRS)
Time frame: 24 hours before (baseline) and at 3 months following unilateral FUS mesencephalotomy
Secondary Outcomes
Patient Global Impression of Change and the Pain Domain from the PROMIS Inventory including items for intensity, quality, behavior and interference.
Time frame: baseline to 3 months post-treatment
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The University of Texas Southwestern Medical Center
Dallas, Texas, United States
NOT_YET_RECRUITINGBaylor College of Medicine
Houston, Texas, United States
NOT_YET_RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITING