Diseases and Abnormalities at or Before Birth

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Neoplasms

Rare Diseases

Congenital Abnormalities

Intracranial Arteriovenous Malformations

Arteriovenous Malformations

Hemangioma

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Cardiovascular Abnormalities

Vascular Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Central Nervous System Vascular Malformations

Nervous System Malformations

Intracranial Arterial Diseases

Intracranial Arteriovenous Malformation

1. AVM patients' age under 18-years-old who underwent intervention in investigators' institution.
2. Patients' lesions were located in eloquent and confirmed by image.

1. AVM patients' age over 18-years-old who underwent intervention in investigators' institution.
2. Patients' lesions were located in eloquent and confirmed by image.

Ruinan Li, MD

Yuanli Zhao, MD

Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.

Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview.

Study overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs\<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years.

Sample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery.

Study endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention.

Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes

Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation

The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.

No significant disability. Able to carry out all usual activities, despite some symptoms.

Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Dead

Confirmed by postoperative DSA or MRI/magnetic resonance angiography

Peking University International Hospital

yuanli Zhao

Chairman of Neurosurgical center

Aneurysm

Brain Neoplasms

Intracranial Aneurysm

Central Nervous System Neoplasms

Nervous System Neoplasms

We will set up 2 navigation systems, newly developed AR-based navigation and conventional navigation system, to surgeries of all participants.

Surgeons will perform all surgical planning and operations with reference to the conventional navigation system. In this process, the errors of the existing navigation and the newly developed navigation will be measured and compared in 3D at several points, and the points are as follows:

1. Fiducial markers
2. Nasion
3. Tumor's margin (anterior, posterior, superior, inferior)

The surgeon will perform all surgical planning and operations with reference to the existing navigation. In this process, the errors of the existing navigation and the newly developed navigation are measured and compared in 3D at several points, and the points are as follows.

1. Fiducial markers
2. Nasion
3. Tumor's margin (anterior, posterior, superior, inferior)

AR-based navigation

Ho Kang, MD

Chul-Kee Park, MD, PhD

The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:

• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.

Participants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.

Being developed AR navigation were reported in our following papers:

1. Dho YS, et al., Development of an inside-out augmented reality technique for neurosurgical navigation. Neurosurgical Focus. 2021 Aug 1;51(2):E21. (doi.org/10.3171/2021.5.FOCUS21184)
2. Moon HC, et al., Navigation of frameless fixation for gamma knife radiosurgery using fixed augmented reality. Scientific Reports. 2022 Mar 16;12(1):1-0. (doi.org/10.3171/2021.5.FOCUS21184)

This study aims to evaluate the accuracy of anatomical localization of a newly developed augmented reality-based neurosurgery navigation. After 3-dimensional (3D) modeling of the brain of a patient with brain tumor or cerebral vascular disease through 3D image segmentation extraction and modeling, the Augmented Reality (AR)-based navigation developed by this research team can be used with a commercially available visualization device, such as iPad, iPhone, and Hololens2, to evaluate the accuracy.

The AR-based navigation obtained approval from the Ministry of Food and Drug Safety of Republic of Korea (class 2 medical device) in February 2022. Through this clinical tria that compare accuracy with existing conventional intraoperative neuronavigation system, we will evaluate whether it shows equivalent performance to replace the existing navigation.

Patients who undergo craniotomy using navigation system for cerebral disease in a single institution

Clinical Trial for the Validation of AR Based Neuronavigation System

Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System

Statistical comparison of the average value between the error with the actual position of conventional navigation and the error with the actual position of AR navigation.

Time required to match conventional navigation and AR navigation, respectively.

Economic benefits that can be expected if AR-based navigation can replace conventional navigation will be assessed. Cost for surgery, cost of whole admission period, and hospital day will be evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes	NCT04593966	Cerebral Arteri...		1 Year - 80 Years	Beijing Tiantan Hospital
Clinical Trial for the Validation of AR Based Neuronavigation System	NCT05776706	Brain Neoplasms Cerebral Aneury... Cerebral Arteri... Navigation, Spa...	AR-based naviga...	18 Years - 85 Years	Seoul National University Hospital
Clinical Trial for the Validation of AR Based Neuronavigation System	NCT05776706	Brain Neoplasms Cerebral Aneury... Cerebral Arteri... Navigation, Spa...	AR-based naviga...	18 Years - 85 Years	Seoul National University Hospital

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