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

NCT05490381 | Withdrawn Phase 1 DMC FDA Drug

• 3 other identifiers: RG1121599NCI-2022-05693STUDY00009998
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm in the Head and Neck; Metastatic Malignant Neoplasm in the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  Defined as the volume of blood lost (mL) from skin incision to skin closure.

  Intraoperatively

Secondary Outcomes (4)

• Perioperative blood transfusion volume

  Intraoperatively and until 48 hours postoperatively

• Surgical procedure time

  Time (minutes) from skin incision to skin closure

• Success of embolization

  Directly after the embolization

• Adverse events (AE) related to angiography or embolization

  Directly after embolization and for 24 hours post-embolization

Study Arms (1)

Treatment (PVA, EOV, tumor vessel embolization)

EXPERIMENTAL

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; Procedure: Angiogram; Procedure: Arterial Embolization; Drug: Polyvinyl Alcohol; Drug: Ethiodized Oil; Procedure: Computed Tomography; Other: Chart Abstraction

Interventions

Iodixanol OTHER

Given via injection

Also known as: Indixanol, OptiPrep, Visipaque

Treatment (PVA, EOV, tumor vessel embolization)

Angiogram PROCEDURE

Undergo diagnostic cerebral angiogram

Treatment (PVA, EOV, tumor vessel embolization)

Arterial Embolization PROCEDURE

Undergo tumor vessel embolization

Also known as: TAE, Transarterial Embolization

Treatment (PVA, EOV, tumor vessel embolization)

Polyvinyl Alcohol DRUG

Given via catheter

Also known as: 9002-89-5, Polydesis, Polyviol, Poval 420, PVA, Vinarol DT

Treatment (PVA, EOV, tumor vessel embolization)

Ethiodized Oil DRUG

Given via catheter

Also known as: 8008-53-5, Ethiodol, iodized oil, Lipiodol

Treatment (PVA, EOV, tumor vessel embolization)

Computed Tomography PROCEDURE

Undergo head and neck CT scans

Also known as: CAT Scan, Computed Axial Tomography, CT SCAN

Treatment (PVA, EOV, tumor vessel embolization)

Chart Abstraction OTHER

Ancillary studies

Treatment (PVA, EOV, tumor vessel embolization)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Guerbet: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

iodixanol; Polyvinyl Alcohol; Ethiodized Oil; Iodized Oil

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Melanie Walker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Do Lim

  Fred Hutch/University of Washington Cancer Consortium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: December 21, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)