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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given via injection
Undergo diagnostic cerebral angiogram
Undergo tumor vessel embolization
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Intraoperative blood loss
Defined as the volume of blood lost (mL) from skin incision to skin closure.
Time frame: Intraoperatively
Perioperative blood transfusion volume
Defined as the volume (mL) of packed red blood cells infused.
Time frame: Intraoperatively and until 48 hours postoperatively
Surgical procedure time
Defined as the amount of time (minutes) from skin incision to skin closure.
Time frame: 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.
Time frame: Directly after the embolization
Adverse events (AE) related to angiography or embolization
Defined as neurological deficit(s) on clinical examination.
Time frame: Directly after embolization and for 24 hours post-embolization
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Given via catheter
Given via catheter
Undergo head and neck CT scans
Ancillary studies