NIPH Clinical Trials Search

A study to evaluate the effectiveness of a less invasive catheter treatment for brain tumors

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Intracranial tumor with radiological evidence of tumor growth
Date of first enrollment	25/11/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	A mixture of n-butyl-2-cyanoacrylate (NBCA) and iodized ethyl esters of fatty acids of poppyseed oil (Lipiodol) will be selectively injected into tumor-feeding arteries using a microcatheter. Under fluoroscopic guidance, the microcatheter will be advanced as close to the tumor as safely possible. Once embolization is achieved, the catheter will be promptly withdrawn. If multiple feeding arteries are present, the same procedure will be repeated within safe limits. The procedure will be performed via a percutaneous endovascular approach under local anesthesia or intravenous sedation.

Outcome(s)

Primary Outcome

The primary endpoint will be the quantitative assessment of contrast-enhancing tumor volume and the rate of volumetric change on contrast-enhanced MRI at 180 days postoperatively.

Secondary Outcome

1. Embolized arteries 2. Embolization outcome and the use of embolic materials other than Histoacryl 3. Procedure-related complications 4. Evaluation of symptomatic cerebral infarction on diffusion-weighted MRI the day after the procedure 5. Quantitative evaluation of contrast-enhancing tumor volume on contrast-enhanced brain MRI at 1 day and 30 days post-procedure 6. Quantitative evaluation of tumor-enhanced volume and volume change rate on contrast-enhanced MRI at 90 days after treatment 7. Karnofsky Performance Status (KPS) and modified Rankin Scale (mRS) score at discharge and 180 days after the procedure 8. Presence or absence of additional treatments during the observation period (such as Surgical resection and Radiation therapy)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Patients aged 18 years or older 2. Patients with suspected meningioma showing a tendency to increase in size on MRI 3. No exclusion based on history of cancer 4. Patients who have provided written informed consent based on their own free will after receiving a full explanation and fully understanding the study. In cases where the patient is unable to provide valid consent due to conditions such as aphasia, written consent must be obtained from a legally authorized representative. 5. Patients eligible for percutaneous endovascular surgery under local anesthesia or intravenous sedation
Exclude criteria	1. Patients with tumor lesions showing significant midline shift or brain edema requiring craniotomy for tumor resection 2. Patients with tumor lesions fed predominantly by prominent intradural arteries 3. Patients diagnosed with Neurofibromatosis type II 4. Patients diagnosed with tumor lesions in the cranial bone (including intraosseous meningioma) 5. Patients with a Karnofsky Performance Status (KPS) score of 70 or lower, or a modified Rankin Scale (mRS) score of 4 or higher. 6. Patients judged to be unable to safely undergo examination due to severe aphasia or higher brain dysfunction 7. Patients with bleeding tendencies, coagulation disorders, or severe renal dysfunction (eGFR <30 mL/min/1.73 m2) 8. Patients with an allergy to contrast media 9. Patients with a history of hypersensitivity to iodine 10. Patients with severe thyroid disease 11. Patients with hypersensitivity to cyanoacrylate, formaldehyde, or dyes (D&C Violet No. 2) 12. Pregnant or breastfeeding patients 13. Any other patients judged by the principal investigator or sub-investigators to be inappropriate as study subjects