Super-Selective Intra-Arterial Embolization of Hypervascular Head and Neck Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- University of Washington
- Locations
- 1
- Primary Endpoint
- Intraoperative blood loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Iodixanol (Other)
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Angiogram (Procedure)
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Arterial Embolization (Procedure)
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Polyvinyl Alcohol (Drug)
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Ethiodized Oil (Drug)
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Computed Tomography (Procedure)
Treatment (PVA, EOV, tumor vessel embolization)
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.
Intervention: Chart Abstraction (Other)
Outcomes
Primary Outcomes
Intraoperative blood loss
Time Frame: Intraoperatively
Defined as the volume of blood lost (mL) from skin incision to skin closure.
Secondary Outcomes
- Success of embolization(Directly after the embolization)
- Adverse events (AE) related to angiography or embolization(Directly after embolization and for 24 hours post-embolization)
- Perioperative blood transfusion volume(Intraoperatively and until 48 hours postoperatively)
- Surgical procedure time(Time (minutes) from skin incision to skin closure)