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

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Guerbet
• Treatments: Ethiodized Oil

Criteria

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