Malignant Neoplasm in the Head and Neck, Metastatic Malignant Neoplasm in the Head and Neck
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHERIodixanol
Given via injection
PROCEDUREAngiogram
Undergo diagnostic cerebral angiogram
PROCEDUREArterial Embolization
Undergo tumor vessel embolization
Given via catheter
DRUGEthiodized Oil
Given via catheter
PROCEDUREComputed Tomography
Undergo head and neck CT scans
OTHERChart Abstraction
Ancillary studies
Sponsors
Guerbet
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | Intraoperatively | Defined as the volume of blood lost (mL) from skin incision to skin closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative blood transfusion volume | Intraoperatively and until 48 hours postoperatively | Defined as the volume (mL) of packed red blood cells infused. |
| Surgical procedure time | Time (minutes) from skin incision to skin closure | Defined as the amount of time (minutes) from skin incision to skin closure. |
| Success of embolization | Directly after the embolization | Defined as percent reduction in vascular blush from tumor supply vessels on catheter angiogram. |
| Adverse events (AE) related to angiography or embolization | Directly after embolization and for 24 hours post-embolization | Defined as neurological deficit(s) on clinical examination. |
Countries
United States
Outcome results
None listed