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

Overview

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.

Full Title of Study: “Super-Selective Intra-arterial Embolization of Hypervascular Head and Neck Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2023

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

  • Other: Iodixanol
    • Given via injection
  • Procedure: Angiogram
    • Undergo diagnostic cerebral angiogram
  • Procedure: Arterial Embolization
    • Undergo tumor vessel embolization
  • Drug: Polyvinyl Alcohol
    • Given via catheter
  • Drug: Ethiodized Oil
    • Given via catheter
  • Procedure: Computed Tomography
    • Undergo head and neck CT scans
  • Other: Chart Abstraction
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Intraoperative blood loss
    • Time Frame: Intraoperatively
    • Defined as the volume of blood lost (mL) from skin incision to skin closure.

Secondary Measures

  • Perioperative blood transfusion volume
    • Time Frame: Intraoperatively and until 48 hours postoperatively
    • Defined as the volume (mL) of packed red blood cells infused.
  • Surgical procedure time
    • Time Frame: Time (minutes) from skin incision to skin closure
    • Defined as the amount of time (minutes) from skin incision to skin closure.
  • Success of embolization
    • Time Frame: 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
    • Time Frame: Directly after embolization and for 24 hours post-embolization
    • Defined as neurological deficit(s) on clinical examination. AE/serious(S)AE will be assessed, and estimates obtained using simple binomial proportions. Primary safety endpoints will be further evaluated as per the Data And Safety Monitoring Plan (DSMP).

Participating in This Clinical Trial

Inclusion Criteria

  • Primary or metastatic extra-axial head and neck tumor greater than 2 cm – Vascular supply from one or more branches of the external carotid artery – Planned surgical resection – All stages – 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) less than 30 mL/min/1.73 m^2 (performed within 30 days of screening) – 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, but not limited to, 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • Guerbet
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Melanie Walker, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium
  • Overall Contact(s)
    • Do Lim, 206-744-9389, dolim@uw.edu

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