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

University of Washington

Status and phase

Withdrawn

Phase 1

Conditions

Malignant Neoplasm in the Head and Neck

Metastatic Malignant Neoplasm in the Head and Neck

Treatments

Procedure: Arterial Embolization

Drug: Polyvinyl Alcohol

Other: Chart Abstraction

Procedure: Computed Tomography

Procedure: Angiogram

Other: Iodixanol

Drug: Ethiodized Oil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05490381

STUDY00009998 (Other Identifier)

NCI-2022-05693 (Registry Identifier)

RG1121599

Details and patient eligibility

About

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 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Treatment (PVA, EOV, tumor vessel embolization)

Experimental group

Description:

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.