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Neoplasms, Vascular Tissue

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Brain Diseases

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Central Nervous System Vascular Malformations

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Intracranial Arterial Diseases

Intracranial Arteriovenous Malformation

fMRI Navigation AVM resection in AVM patients

intraoperative fMRI navigation guided resection in AVM patients

fMRI Navigation AVM resection

conventional resection

Yong Cao, MD

Shuo Wang, MD

Little is known about the effect of fMRI navigation in the intracranial arteriovenous malformation surgery. The investigators aim to perform a multicenter prospective randomized single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain arteriovenous malformation surgery.

Intracranial arteriovenous malformations (AVMs) are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without an intervening normal capillary bed. Surgical removal is thought as a major treatment option for AVMs. However, compared with stereotaxic radiosurgery and endovascular embolization, microsurgery of AVMs is regarded with high mortality and morbidity, particular for high level classification AVMs .

Blood oxygen level dependent fMRI can be used to mapping the motor and language regions of the brain noninvasively. It has been one of the most advanced functional imaging techniques and it has quickly grown to be a vital tool for clinical and cognitive neuroscience research. Many clinical researches have been reported about the utility of fMRI in brain tumor surgery. However, the effect of fMRI navigation for neurofunction protection in the intracranial arteriovenous malformation surgery was unclear.

We aim to perform a multicenter prospective randomized single -blind clinical trial to assess the safety and effect of fMRI navigation in the intracranial AVMs surgery. We hypothesize that application of blood oxygen level dependent fMRI is able to improve long term prognosis of patients.

Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery

Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial

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

1. No significant disability. Able to carry out all usual activities, despite some symptoms.
2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. Moderate disability. Requires some help, but able to walk unassisted.
4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. Dead.

Post operative epilepsy seizure, hemorrhage,infarction.

Beijing Tiantan Hospital

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

We plan to perform PET scanning on the patients with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806（1-2mCi）, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, we precisely obtained the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status was detected by Sanger sequencing to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. The final goal was to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.

Patients will be given IV bolus injection of 89Zr-ABT806(1-2mCi). The first 89Zr-ABT806 PET scan will be performed about 72 to 120 hours after injection of tracer. The second 89Zr-ABT806 PET scan will be performed about 120 to 168 hours after injection of tracer. Semi-quantitative analysis was performed using the maximum standardized uptake value (SUVmax) and T/N ratio.

89Zr-ABT806 PET

Dongxiao Zhuang, Professor

Liangfu Zhou, Professor

Nijiati Kudulaiti, M.D.

Dongxiao Zhuang, M.D. Ph.D.

Zhemin Huang, M.D.

Chengjun Yao, M.D. Ph.D.

Tainming Qiu, M.D. Ph.D.

Junfeng Lu, M.D. Ph.D.

Huiwei Zhang, M.D.

Zhengwei Zhang, M.D.

Yihui Guan, M.D. Ph.D.

Jingsong Wu, M.D. Ph.D.

Zhifeng Shi, M.D. Ph.D.

Jie Zhang, M.D. Ph.D.

Fangyuan Gong, M.D.

Zhengda Yv, M.D.

The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because of the heterogeneity of tumor. It is also not applicable for patients who are not suitable for surgical procedure due to the tumor location or patients' general conditions. Because of the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis, maintenance, and progression of high grade glioma, there has been an intense effort to develop noninvasive molecular imaging approach for the selection and monitoring of EGFR-targeted therapies.

Based on investigators' previous study, investigators plan to perform PET scanning on the participants with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, investigators precisely obtain the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.

The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma

The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma and Its Correlation to EGFRvIII

After fusing the 89Zr-ABT806 PET and MRI images, investigators precisely obtained the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be analyzed by molecular methods. The sensitivity and specificity of 89Zr-ABT806 PET will be measured with statistic methods.

Huashan Hospital

Professor

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

use of navigated 3D ultrasound during surgery

Geirmund Unsgaard, MD, PhD

3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.

The degree of resection as judged by the surgeon is recorded at the end of surgery for each patient, and then compared with the postoperative MRI. Neurological status before and after surgery, QOL before surgery and at follow-up as well as survival is recorded.

Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

St. Olavs Hospital

Norwegian University of Science and Technology

All Drugs and Chemicals

Dihydroxyphenylalanine

Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.

Surgical neuronavigation with 18F-DOPA PET imaging

Alan Nichol, MD

The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.

Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study

A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection

Alan Nichol

Radiation Oncologist

Aneurysm

Intracranial Aneurysm

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
Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery	NCT01758211	Intracranial Ar...	fMRI Navigation... conventional re...	12 Years - 60 Years	Beijing Tiantan Hospital
The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma	NCT03058198	Glioma	89Zr-ABT806 PET	18 Years -	Huashan Hospital
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study	NCT00233350	Brain Neoplasms	use of navigate...	18 Years -	Norwegian University of Science and Technology
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study	NCT00233350	Brain Neoplasms	use of navigate...	18 Years -	Norwegian University of Science and Technology
Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study	NCT01248754	Cancer (High-gr...	Surgical neuron...	18 Years -	British Columbia Cancer Agency
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
Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study	NCT01248754	Cancer (High-gr...	Surgical neuron...	18 Years -	British Columbia Cancer Agency

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