Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes (NCT05490381) | Clinical Trial Compass
WithdrawnPhase 1
Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes
Stopped: Study closed due to no accruals and change in the standard of care for this population
United States0Started 2023-12-21
Plain-language summary
This phase I trial tests whether embolization done prior to surgery (preoperative) will improve surgical outcomes in head and neck tumors with large amounts of blood vessels (hypervascular). Embolization is a minimally invasive surgical technique performed under angiographic (imaging of blood vessels) guidance. Embolization therapy injects tiny particles into the arteries feeding tumors to cut off their blood supply which may help improve outcomes by preventing blood loss during surgery, reducing surgical times, and shrinking tumors or reducing recurrence.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary or metastatic extra-axial tumor involving one or more anatomic structures in the head and neck
* Vascular supply from one or more branches of the external carotid artery
* Planned surgical resection
* All stages
* Extra-axial head and neck tumor greater than 1 cm in any dimension
* Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the head and/or neck
* Subjects who have undergone prior therapies are eligible
* Adults aged 18-80; no data outside this age range
* Minimum of 3-month life expectancy
* Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m\^2
* Subjects must be non-pregnant at the time of angiographic intervention
* Resectable tumor as determined by the Tumor Board
* Medically stable at the time of the planned intervention, despite potential comorbidities
* In English or Spanish. All study materials have been professionally translated into Spanish
Exclusion Criteria:
* Recent hemorrhage or trauma
* Pregnancy
* Nursing mothers
* Contrast medium allergy
* Hypersensitivity or known allergy to ethiodized oil, poppy seeds, or poppy seed oil
* Uncontrolled or concurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnancy is a contraindication to angiography outside of the emergency setting
* A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.