Clinical trial NCT05490381: Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes
Official title: Super-Selective Intra-Arterial Embolization of Hypervascular Head and Neck Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Malignant Neoplasm in the Head and Neck
Metastatic Malignant Neoplasm in the Head and Neck
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2022-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: Intraoperatively
Secondary outcomes:
measure: Perioperative blood transfusion volume
timeFrame: Intraoperatively and until 48 hours postoperatively
measure: Surgical procedure time
timeFrame: Time (minutes) from skin incision to skin closure
measure: Success of embolization
timeFrame: Directly after the embolization
measure: Adverse events (AE) related to angiography or embolization
timeFrame: Directly after embolization and for 24 hours post-embolization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Melanie Walker
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Do Lim
role: STUDY_DIRECTOR
References: