Preoperative Embolization for Highly Vascular Brain Tumors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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. Pre-procedural neurological and diagnostic cross-sectional imaging (contrast-enhanced MRI or CT angiography). 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. Microsurgical tumor resection within 24 to 72 hours following the embolization procedure.
Researchers will assess the degree of tumor devascularization achieved, the volume of intraoperative blood loss, blood transfusion requirements, total surgical duration, extent of tumor resection, and the occurrence of any procedure-related complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Preoperative Endovascular Embolization
Procedure/SurgeryDiagnostic 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.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Preoperative Embolization and Surgical ResectionExperimental treatment 1 intervention
Trial outcomes
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%).
Time frame
24 hours post-embolizationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: