NCT07405645 Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy
| NCT ID | NCT07405645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Head Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-15 |
| Primary Completion | 2028-12-31 |
Trial Parameters
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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.
Eligibility Criteria
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 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 de
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