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Malignant Neoplasm in the Head and NeckPhase 1NCT05490381

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

A Phase 1 study testing Iodixanol, Angiogram and Arterial Embolization in people with Malignant Neoplasm in the Head and Neck and Metastatic Malignant Neoplasm in the Head and Neck, run by University of Washington at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Iodixanol, Angiogram and Arterial Embolization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
21 Dec 2023to 31 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Super-Selective Intra-Arterial Embolization of Hypervascular Head and Neck Tumors

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.

Read the 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.

Being tested
Iodixanol, Angiogram, Arterial Embolization, Polyvinyl Alcohol, Ethiodized Oil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IodixanolOther

    Also called Indixanol, OptiPrep, Visipaque

    Given via injection

  • AngiogramProcedure or surgery

    Undergo diagnostic cerebral angiogram

  • Arterial EmbolizationProcedure or surgery

    Also called TAE, Transarterial Embolization

    Undergo tumor vessel embolization

  • Polyvinyl AlcoholDrug

    Also called 9002-89-5, Polydesis, Polyviol, Poval 420

    Given via catheter

  • Ethiodized OilDrug

    Also called 8008-53-5, Ethiodol, iodized oil, Lipiodol

    Given via catheter

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, Computed Axial Tomography, CT SCAN

    Undergo head and neck CT scans

  • Chart AbstractionOther

    Ancillary studies

Study groups in NCT05490381
Study groupRoleWhat they receive
Treatment (PVA, EOV, tumor vessel embolization)ExperimentalPatients 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.
Receives: Other: Iodixanol; Procedure: Angiogram; Procedure: Arterial Embolization; Drug: Polyvinyl Alcohol; Drug: Ethiodized Oil; Procedure: Computed Tomography; Other: Chart Abstraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative blood loss

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

    Measured: Intraoperatively

Secondary outcomes (4)

  1. Perioperative blood transfusion volume

    Defined as the volume (mL) of packed red blood cells infused.

    Measured: Intraoperatively and until 48 hours postoperatively

  2. Surgical procedure time

    Defined as the amount of time (minutes) from skin incision to skin closure.

    Measured: Time (minutes) from skin incision to skin closure

  3. Success of embolization

    Defined as percent reduction in vascular blush from tumor supply vessels on catheter angiogram.

    Measured: Directly after the embolization

  4. Adverse events (AE) related to angiography or embolization

    Defined as neurological deficit(s) on clinical examination.

    Measured: Directly after embolization and for 24 hours post-embolization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start21 Dec 2023 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Why it stopped: Study closed due to no accruals and change in the standard of care for this population

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490381
Sponsor's protocol ID
RG1121599
Other IDs
NCI-2022-05693, STUDY00009998
Status last verified
Oct 2023
First submitted
3 Aug 2022
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Iodixanol, Angiogram and Arterial Embolization in people with Malignant Neoplasm in the Head and Neck and Metastatic Malignant Neoplasm in the Head and Neck, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative blood loss (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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