Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head & Neck Cancer

Jeff Elias, MD1 site in 1 country6 target enrollmentJune 22, 2020

ConditionsCancer of Head and Neck Pain, Face Pain, Neck

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer of Head and Neck
Sponsor: Jeff Elias, MD
Enrollment: 6
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer

Detailed Description

This pilot study is designed as a prospective, open-label clinical trial of stereotactic FUS mesencephalotomy in 6 subjects with treatment-refractory pain from head and neck cancer. Primary safety assessments will be made throughout the study period of 6 months following the procedure. Primary efficacy outcome is determined by comparing the difference in baseline NPRS to 3 months post treatment. All subjects receiving treatment will be followed for the six month study period.

Registry

clinicaltrials.gov

Start Date

June 22, 2020

End Date

August 31, 2025

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jeff Elias, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Jeff Elias, MD

Professor of Neurological Surgery

University of Virginia

Eligibility Criteria

Inclusion Criteria

•Men and women, between 18 and 75 years, inclusive
•Subjects with head and neck 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
•Craniofacial or cervical 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 6 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

Exclusion Criteria

•Idiopathic trigeminal neuralgia
•Trigeminal neuropathic pain from trauma, infection, or iatrogenic
•Post-herpetic neuralgia
•Headache syndromes like migraine, cluster headache
•Temporomandibular joint syndrome
•Atypical facial pain or pain related to a somatoform disorder
•Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:
•Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain
•Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
•Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)

Outcomes

Primary Outcomes

Adverse Events

Time Frame: 6 months post-intervention

Number of participants with treatment-related adverse events, as assessed from adverse event reporting throughout the 6 month study period. Additional measures of safety will be made with MRI evaluation.

Numeric Pain Rating Scale

Time Frame: 3 months post-intervention (will also be assessed at 7 days, 1 month, and 6 months post-intervention)

Will compare the change of WORST pain experienced in 24 hours before (baseline) and at 3 months following unilateral FUS mesencephalotomy as determined from the 11-point numeric pain rating scale (0-10), with 0 being no pain and 10 being the worst pain imaginable.

Secondary Outcomes

Precision of lesion in the x, y, z dimensions and two dimensional radial vector in mm(7 days and 3 months post-intervention)
PROMIS scale v1.0 - Pain Intensity 3a(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS scale v1.0 - Pain Behavior 7a(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
Daily morphine equivalents (milligrams)(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
Patient Global Impression of Change(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS scale v2.0 - Nociceptive Pain Quality 5a(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS scale v1.0 - Pain Interference 8a(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS - Ca Item Bank v1.0 - Emotional Distress-Anxiety(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS scale v2.0 - Neuropathic Pain Quality 5a(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS - Ca Item Bank v1.0 - Fatigue(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
Location of lesion in the x, y, z dimensions in mm(7 days and 3 months post-intervention)
PROMIS - Ca Item Bank v1.0 - Emotional Distress-Depression(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
PROMIS - Ca Bank v1.1 - Physical Function(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
Pain Catastrophizing Scale(Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention)
Volume of lesion in mm3(7 days and 3 months post-intervention)