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New treatment option for Head Neck Cancer
Official title Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy
ClinicalTrials.gov ID: NCT07405645
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Men and women, between 18 and 85 years, inclusive
- people 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...
- Cancer occurring in the nasopharynx, skin, thyroid gland, and eye
- Cancer involving the brachial region including brachial plexus, upper lung apex, and Pancoast tumors.
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- Men and women, between 18 and 85 years, inclusive
- people 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...
- 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...
- people who are able and willing to give consent and able to attend all study visits
- people who are able to communicate sensations during the focused ultrasound treatment
What rules you out
- 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
- people deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:
- Subject deemed by their oncologist to have limited life expectancy for outcome assessment. At least 3 months life expectancy is required to obtain the primary how well it works outcome measure.
- Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain
- people 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...
- Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of...
- people with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
- Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
- been hospitalized for the treatment of a psychiatric illness within the past 2 years
- received transcranial magnetic stimulation for depression treatment
- received electroconvulsive therapy for depression
- any presence or history of psychosis
- people with unstable cardiac status including:
- Unstable angina pectoris on medication
- people with documented myocardial infarction within six months of protocol entry
- Significant congestive heart failure defined with ejection fraction \< 40
- people with unstable ventricular arrhythmias
- people with atrial arrhythmias that are not rate-controlled
- Severe hypertension (diastolic BP \> 100 on medication)
- people with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- On medications that increases the bleeding risk, based on the published guidelines which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and...
- Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abiciximab) for the last 7 days prior to treatment.
- Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours.
- Intravenous or subcutaneous heparin-derived compounds for the last 48 hours.
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)
- people participating or have participated in another pain management clinical trial in the last 30 days
- people with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits.
- people with brain tumors or any significant intracranial mass that impedes the acoustic beam. people with cerebral metastasis may be included if the lesion(s) do not affect the FUS treatment.
- Any illness that in the investigator's opinion preclude participation in this study
- Pregnancy or lactation
- Legal incapacity or limited legal capacity
- people with a deep brain stimulation implant
- Skull density ratio, calculated from the baseline noncontrasted head CT, is less than 0.4
- History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
- people whose primary pain is other than craniofacial or brachial neuropathic pain.
- Patients deemed high risk because of their airway for the procedure as evaluated by anesthesia.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Portland, Oregon, United States; Dallas, Texas, United States; Houston, Texas, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.