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

NCT05490381 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-12-12

No results posted yet for this study

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

Interventions

OTHER

Iodixanol

Given via injection

PROCEDURE

Angiogram

Undergo diagnostic cerebral angiogram

PROCEDURE

Arterial Embolization

Undergo tumor vessel embolization

DRUG

Polyvinyl Alcohol

Given via catheter

DRUG

Ethiodized Oil

Given via catheter

PROCEDURE

Computed Tomography

Undergo head and neck CT scans

OTHER

Chart Abstraction

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Melanie Walker · Fred Hutch/University of Washington Cancer Consortium

  • Do Lim · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490381 on ClinicalTrials.gov