Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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OUTLINE: Patients receive iodixanol via injection and undergo diagnostic cerebral angiogram over 30 minutes. If the tumor blood supply is suitable, patients undergo tumor vessel embolization with polyvinyl alcohol (PVA) suspended in ethiodized oil (EOV) and delivered via a catheter. Patients also undergo head and neck computed tomography (CT) scans immediately after completion of tumor vessel embolization, and again between 2-3 months later. After completion of study, patients are followed for up to 6 months.

Official Title
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Super-Selective Intra-Arterial Embolization of Hypervascular Head and Neck Tumors

Conditions
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Malignant Neoplasm in the Head and Neck, Metastatic Malignant Neoplasm in the Head and Neck

Intervention / Treatment
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* Other: Iodixanol
* Procedure: Angiogram
* Procedure: Arterial Embolization
* Drug: Polyvinyl Alcohol
* Drug: Ethiodized Oil
* Procedure: Computed Tomography
* Other: Chart Abstraction


Participation Criteria
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Eligibility Criteria
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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 Active thyroid disease may be affected by iodinated products Subject is participating in another clinical trial at the enrollment of the study or duration of the study that can affect the treatment and outcome of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (PVA, EOV, tumor vessel embolization)<br>Patients receive iodixanol via injection and undergo diagnostic cerebral angiogram over 30 minutes. If the tumor blood supply is suitable, patients undergo tumor vessel embolization with PVA suspended in EOV and delivered via a catheter. Patients also undergo head and neck CT scans immediately after completion of tumor vessel embolization, and again between 2-3 months later. | Other: Iodixanol<br>* Given via injection<br>* Other names: Visipaque;Procedure: Angiogram<br>* Undergo diagnostic cerebral angiogram<br>Procedure: Arterial Embolization<br>* Undergo tumor vessel embolization<br>* Other names: Transarterial Embolization;Drug: Polyvinyl Alcohol<br>* Given via catheter<br>* Other names: Vinarol DT;Drug: Ethiodized Oil<br>* Given via catheter<br>* Other names: Lipiodol;Procedure: Computed Tomography<br>* Undergo head and neck CT scans<br>* Other names: CT SCAN;Other: Chart Abstraction<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Defined as the volume of blood lost (mL) from skin incision to skin closure. | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood transfusion volume | Defined as the volume (mL) of packed red blood cells infused. | Intraoperatively and until 48 hours postoperatively | 
| Surgical procedure time | Defined as the amount of time (minutes) from skin incision to skin closure. | Time (minutes) from skin incision to skin closure | 
| Success of embolization | Defined as percent reduction in vascular blush from tumor supply vessels on catheter angiogram. | Directly after the embolization | 
| Adverse events (AE) related to angiography or embolization | Defined as neurological deficit(s) on clinical examination. | Directly after embolization and for 24 hours post-embolization |