Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes
NCT ID: NCT05490381
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2023-12-21
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Iodixanol
Given via injection
Angiogram
Undergo diagnostic cerebral angiogram
Arterial Embolization
Undergo tumor vessel embolization
Polyvinyl Alcohol
Given via catheter
Ethiodized Oil
Given via catheter
Computed Tomography
Undergo head and neck CT scans
Chart Abstraction
Ancillary studies
Interventions
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Iodixanol
Given via injection
Angiogram
Undergo diagnostic cerebral angiogram
Arterial Embolization
Undergo tumor vessel embolization
Polyvinyl Alcohol
Given via catheter
Ethiodized Oil
Given via catheter
Computed Tomography
Undergo head and neck CT scans
Chart Abstraction
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Guerbet
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Melanie Walker
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Do Lim
Role: STUDY_DIRECTOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2022-05693
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00009998
Identifier Type: OTHER
Identifier Source: secondary_id
RG1121599
Identifier Type: -
Identifier Source: org_study_id