Is NCT07405645 recruiting in Houston, TX?

Yes, NCT07405645 is currently recruiting participants at its Houston, TX location. This head neck cancer clinical trial is actively enrolling qualified participants.

How do I join the head neck cancer clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Head Neck Cancer Clinical Trial in Houston, TX

Who Can Participate

Inclusion Criteria

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.

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

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:

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 efficacy outcome measure.

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)

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 intoxication and physical fights).

Subjects 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

Subjects with unstable cardiac status including:

Unstable angina pectoris on medication

Subjects with documented myocardial infarction within six months of protocol entry

Significant congestive heart failure defined with ejection fraction \< 40

Subjects with unstable ventricular arrhythmias

Subjects with atrial arrhythmias that are not rate-controlled

Severe hypertension (diastolic BP \> 100 on medication)

Subjects 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 the North American Neuromodulation Society (Reg Anesth Pain Med 2015;40: 182-212); specifically:

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.)

Subjects participating or have participated in another pain management clinical trial in the last 30 days

Subjects 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.

Subjects with brain tumors or any significant intracranial mass that impedes the acoustic beam. Subjects 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

Subjects 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

Subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT07405645) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Head Neck Cancer Treatment Options in Houston, TX

If you're searching for head neck cancer treatment options in Houston, TX, this clinical trial (NCT07405645) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced head neck cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all head neck cancer clinical trials near you to find additional studies recruiting in your area.

Head Neck Cancer Clinical Trial in Houston, TX

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