Health TrialsbyHealthPanel

Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy

ConditionsHead Neck CancerSquamous Cell Cancer of Head and Neck (SCCHN)Cancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Virginia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Men and women, between 18 and 85 years, inclusive

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.

Disqualifiers

Idiopathic trigeminal neuralgia

Trigeminal neuropathic pain from trauma, infection, or iatrogenic

Post-herpetic neuralgia

Headache syndromes like migraine, cluster headache

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single Group AssignmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Outcome

Safety as assessed from adverse event reporting.

Time frame
Intervention through 6 months
2

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

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Focused Ultrasound Foundation

Collaborator

Source ClinicalTrials.gov
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