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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Malignant Neoplasm in the Head and Neck; Metastatic Malignant Neoplasm in the Head and Neck
• Intervention / Treatment: Other: Iodixanol; Procedure: Angiogram; Procedure: Arterial Embolization; Drug: Polyvinyl Alcohol; Drug: Ethiodized Oil; Procedure: Computed Tomography; Other: Chart Abstraction

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Do Lim; Phone Number: 206-744-9389; Email: dolim@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Iodixanol; Given via injection; Other Names: Indixanol; OptiPrep; Visipaque; Procedure: Angiogram; Undergo diagnostic cerebral angiogram; Procedure: Arterial Embolization; Undergo tumor vessel embolization; Other Names: TAE; Transarterial Embolization; Drug: Polyvinyl Alcohol; Given via catheter; Other Names: 9002-89-5; Polydesis; Polyviol; Poval 420; PVA; Vinarol DT; Drug: Ethiodized Oil; Given via catheter; Other Names: 8008-53-5; Ethiodol; iodized oil; Lipiodol; Procedure: Computed Tomography; Undergo head and neck CT scans; Other Names: CAT Scan; Computed Axial Tomography; CT SCAN; Other: Chart Abstraction; Ancillary studies

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Guerbet
• Investigators: Principal Investigator: Melanie Walker, Fred Hutch/University of Washington Cancer Consortium; Study Director: Do Lim, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): December 21, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Antineoplastic Agents; Ethiodized Oil
• Other Study ID Numbers: RG1121599; NCI-2022-05693 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STUDY00009998 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No