NCT07823985

Brief Summary

Highly vascular brain tumors, including meningiomas, hemangioblastomas, and certain metastases, have a rich blood supply that can lead to substantial blood loss and technical difficulties during surgical removal. Preoperative endovascular embolization is an adjunctive, catheter-based procedure used to block the feeding blood vessels of the tumor before surgery, aiming to reduce intraoperative bleeding and facilitate safer tumor resection. The primary purpose of this study is to evaluate the technical feasibility, safety, and effectiveness of preoperative endovascular embolization in patients with highly vascular intracranial tumors. Participants enrolled in this prospective study will undergo:

  1. 1.Pre-procedural neurological and diagnostic cross-sectional imaging (contrast-enhanced MRI or CT angiography).
  2. 2.Diagnostic digital subtraction angiography (DSA) to map tumor-feeding arteries, followed by super-selective catheterization to deliver embolic materials (polyvinyl alcohol particles, Onyx, or microcoils).
  3. 3.Microsurgical tumor resection within 24 to 72 hours following the embolization procedure.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

Preoperative EmbolizationEndovascular EmbolizationTumor DevascularizationDigital Subtraction AngiographyIntraoperative Blood LossInterventional NeuroradiologyMicrosurgical Resection

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Achieving Defined Grades of Tumor Devascularization

    Tumor devascularization is determined by comparing post-embolization digital subtraction angiography (DSA) or CT angiography against baseline diagnostic imaging. Participants are categorized into three predefined grades based on devascularization of tumor vascular blush: poor (\<50%), moderate (50% to 80%), or good/complete (\>80%).

    24 hours post-embolization

Study Arms (1)

Preoperative Embolization and Surgical Resection

EXPERIMENTAL

Participants undergo pre-procedural neurological and imaging assessment, followed by diagnostic digital subtraction angiography (DSA) to identify tumor-feeding vessels. Super-selective microcatheterization is performed to deliver embolic agents (polyvinyl alcohol \[PVA\] particles, Onyx, or microcoils) for tumor devascularization. Post-embolization devascularization is evaluated by repeat DSA/CT, followed by microsurgical tumor resection within 24 to 72 hours.

Procedure: Preoperative Endovascular Embolization

Interventions

Diagnostic cerebral digital subtraction angiography (DSA) is performed to identify tumor-feeding arteries and exclude dangerous anastomoses. Super-selective microcatheterization is then conducted to deliver embolic materials (polyvinyl alcohol \[PVA\] particles, Onyx, or microcoils) directly into the tumor vasculature. Tumor devascularization is quantified via post-procedural DSA/CT (\<50%, 50-80%, or \>80%). Following endovascular devascularization, patients undergo microsurgical tumor resection within 24 to 72 hours.

Preoperative Embolization and Surgical Resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a hypervascular brain tumor (e.g., meningioma, hemangioblastoma, or hypervascular metastasis) confirmed by contrast-enhanced MRI or CT
  • Scheduled for preoperative endovascular embolization followed by microsurgical resection

You may not qualify if:

  • Severe, uncorrected coagulopathy
  • Severe allergy to iodinated contrast media
  • Severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m²)
  • Absence of safe arterial access
  • Absence of identifiable tumor-feeding vessels suitable for selective microcatheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain NeoplasmsMeningiomaHemangioblastoma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueMeningeal NeoplasmsHemangioma, CapillaryHemangioma

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Diagnostic and Interventional Radiology

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09