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.
• 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