University of Virginia
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…
Inclusion Criteria: 1. Men and women, between 18 and 85 years, inclusive 2. 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 3. Craniofacial, cervical, or brachial pain related to the cancer that meets al…
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.