Trials / Withdrawn
WithdrawnNCT05490381
Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes
Super-Selective Intra-Arterial Embolization of Hypervascular Head and Neck Tumors
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-12-21
- Primary completion
- 2025-01-31
- Completion
- 2025-01-31
- First posted
- 2022-08-05
- Last updated
- 2023-12-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05490381. Inclusion in this directory is not an endorsement.