Printed from Voxsanity (voxsanity.com.au) — NCT07405645 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Head And Neck Cancer
Head and Neck Cancer Trial, Recruiting
NCT07405645
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a man or woman between 18 and 85 years old
- You have been diagnosed with a cancer in the head, neck, or shoulder/upper chest area — this includes cancers of the nose, sinuses, lips, mouth, salivary glands, throat, voice box, skin, thyroid, eye, nasopharynx, upper lung (including Pancoast tumors), lymphoma, or sarcoma
- You have severe pain in your face, head, neck, or shoulder area caused by your cancer, with a pain score of 5 or higher out of 10, and this level of pain has been present for at least the past two months
- Your pain has lasted for more than 3 months
- You have already tried at least 3 prescription pain medications — including both a weaker and a stronger opioid — without getting enough relief
- A specific part of your brainstem (called the mesencephalon) can be safely targeted by the treatment device, as confirmed by MRI scans
- You are able and willing to give your consent to take part and can attend all required study visits
- You are able to describe and communicate sensations (such as tingling or warmth) during the ultrasound treatment
Who may not be able to join:
- Your pain is caused by a condition other than cancer, such as trigeminal neuralgia, nerve pain from injury or infection, shingles-related nerve pain, migraines, cluster headaches, jaw joint problems, or unexplained facial pain
- A team of cancer and palliative care specialists has concerns about your suitability, for example if your life expectancy is less than 3 months, if there are concerns about the reliability of information you provide, or if you have had significant problems related to alcohol or drug use in the past 12 months
- You are currently having thoughts of suicide, have attempted suicide in the past 2 years, have been hospitalised for a psychiatric condition in the past 2 years, have received certain brain stimulation treatments for depression, or have any history of psychosis
- You have an unstable heart condition, such as unstable chest pain (angina), a heart attack within the last 6 months, significant heart failure, or uncontrolled irregular heart rhythms
- You have severely high blood pressure (a lower blood pressure reading above 100) even while on medication
- You have a metal implant in your body that is not safe for MRI scanning, such as a pacemaker (confirm with trial site)
- You are currently taking blood-thinning or antiplatelet medications (such as aspirin, clopidogrel, warfarin, or similar drugs) within a certain number of days before treatment — the exact timeframes vary by medication (confirm with trial site)
- You are unable or unwilling to lie still on your back for up to 4 hours during the treatment
- You have taken part in another pain management clinical trial in the last 30 days
- You have a condition that causes problems with blood clotting, or your blood clotting test results are outside normal limits
- You have a brain tumour or significant growth inside your skull that could interfere with the ultrasound treatment (brain metastases may be acceptable if they do not affect the treatment — confirm with trial site)
- You are pregnant or breastfeeding
- You do not have the legal capacity to consent to taking part
- You have a deep brain stimulation device implanted
- A measurement of your skull density (taken from a head CT scan) is below a certain threshold (0.4), which may affect how well the ultrasound works
- You have had a bleeding stroke or significant blood vessel event in the brain within the past year that has not fully resolved
- Your main pain is not in the face, head, neck, or shoulder/upper arm area
- Your airway is considered high risk for this procedure, as assessed by an anaesthesia specialist
- You have any other illness that the trial doctor believes would make it unsafe or unsuitable for you to participate (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: William J Elias, MD, University of Virginia
Phone: 434-924-0451
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
15 February 2026
Est. completion
31 December 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Primary Safety Outcome; Primary Efficacy Outcome
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.