Multimodal Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations (MITASREAVM)

The Efficacy of Multimodal Magnetic Resonance Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations

Microsurgical resection for eloquent arteriovenous malformations (AVMs) remains challenging. Currently, there are only two grading systems concerning pretreatment assessment of brain AVMs: the Spetzler-Martin grading system proposed by Spetzler and Martin in 1986 and the supplementary grading system proposed by Lawton in 2010. Controversies exist regarding the treatment timing and treatment modalities for eloquent AVMs. Till now, there is no clinical trial concerning the efficacy of multimodal magnetic resonance imaging techniques in assessing the surgical risk for eloquent AVMs. The investigators assume that multimodal imaging-based grading system is superior to the classic Spetzler-Martin grading system and the supplementary grading system in predicting the surgical risk for eloquent AVMs.

Study Overview

• Status: Unknown
• Conditions: Intracranial Arteriovenous Malformations
• Intervention / Treatment: Procedure: Microsurgical resection of brain AVMs

Detailed Description

Microsurgical resection for eloquent arteriovenous malformations (AVMs) remains challenging. Currently, there are only two grading systems concerning pretreatment assessment of brain AVMs: the Spetzler-Martin grading system proposed by Spetzler and Martin in 1986 and the supplementary grading system proposed by Lawton in 2010. Controversies exist regarding the treatment timing and treatment modalities for eloquent AVMs. Till now, there is no clinical trial concerning the efficacy of multimodal magnetic resonance imaging techniques in assessing the surgical risk for eloquent AVMs. The investigators assume that multimodal imaging-based grading system is superior to the classic Spetzler-Martin grading system and the supplementary grading system in predicting the surgical risk for eloquent AVMs.

This study consists of two parts: a retrospective analysis and a prospective study. Firstly, the investigators will retrospectively review the 250 AVM patients that were surgically treated at Beijing Tiantan Hospital between June 2012 and June 2015. All data of these patients were prospectively maintained in our AVM database. All these patients had preoperative functional magnetic resonance imaging (fMRI) studies. The investigators will collect the patient demographic data, AVM features, the least distances from the AVMs to the activated cortex as well as to the fiber tracts. The investigators will also collect the patient preoperative functional status (modified Rankin scale score, mRS) and the functional status (mRS) six months after surgery. The changes between the two functional status in mRS will be classified into two groups: those with worsened mRS (mRS score six months after surgery - presurgical mRS score >0) and those with unchanged or improved mRS (mRS score six months after surgery - presurgical mRS score ≤0). The new grading system will be proposed based on the multimodal magnetic resonance imaging (MRI). The investigators will compare the predictive accuracy of the three grading systems (the Spetzler-Martin grading system, the supplementary system and our new grading system) in assessing functional status (worsened mRS). Then in the prospective study, the investigators will enroll 400 surgically treated AVM patients from five neurosurgical centers. All patients will meet the inclusion and exclusion criteria. The preoperative preparation, the surgical procedures, the follow-up period, the primary outcomes and statistical analyses will be the same as those in the retrospective study part. Multimodal imaging-based system will be verified in this prospective phase. If the results demonstrate that the multimodal MRI-based grading system is superior to the Spetzler-Martin grading system and the supplementary system in predicting the functional status six months after AVM surgery, the investigators will propose the new AVM grading system in the public.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Cao, M.D.; Phone Number: 100050 861067096510; Email: caoyong6@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Yong Cao, M.D.; Phone Number: 100050 861067096510; Email: caoyong6@hotmail.com
      • Principal Investigator: Shuo Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged between 12 and 60 years
2. Data from preoperative structural MRI, blood oxygen level dependent (BOLD)-fMRI, time-of-flight magnetic resonance angiography (TOF-MRA), and DTI of the motor tract,language tract or optic radiation were available
3. Patients with a definite diagnosis of AVM confirmed by preoperative digital subtraction angiography
4. Patients opting for surgical management at the five centers in this study
5. Patients without any interventional therapy (microsurgery, radiosurgery, endovascular embolization, or multimodality treatment) before admission to the five centers

Exclusion Criteria:

1. Patients with acute intracranial hematoma and resultant brain hernia prompting emergency surgery
2. Patients with a hemorrhagic incident in the past month
3. Nonavailability of BOLD-fMRI and DTI data
4. Patients with other severe diseases that prevented them from having surgery
5. Patients unwilling to participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fMRI guided AVM resection; fMRI guided microsurgical resection of brain AVMs	Procedure: Microsurgical resection of brain AVMs; fMRI guided microsurgical resection of brain AVMs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurologic status measured by modified Rankin scale score	the changes of modified Rankin scale (mRS) score six months after AVM surgery compared with the presurgical mRS score	six months after AVM surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patient deaths	number of patient deaths due to AVM rebleeding or surgery	within 6 months after surgery
AVM obliteration confirmed by postoperative DSA or CTA	AVM obliteration on DSA or CTA	within one week after surgery
AVM rebleeding confirmed by CT scan	AVM rebleeding confirmed by CT scan within 6 months after surgery	within 6 months after surgery
Seizure control measured by Engel classification	Seizure control or new seizure onset according to Engel classification within 6 months after surgery	within 6 months after surgery
muscle strength measured by muscle strength grading scale	muscle strength according to muscle strength grading scale 6 months after surgery	6 months after surgery
number of patients with aphasia	number of patients with aphasia measured by Western Aphasia Battery (WAB) 6 months after surgery	6 months after surgery
number of patients with visual field defect	number of patients with visual field defect measured by visual field testing 6 months after surgery	6 months after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Friendship Hospital; Chinese PLA General Hospital; Xuanwu Hospital, Beijing; Beijing Hospital
• Investigators: Study Chair: Shuo Wang, M.D., Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Jiao Y, Lin F, Wu J, Li H, Fu W, Huo R, Cao Y, Wang S, Zhao J. Plasticity in language cortex and white matter tracts after resection of dominant inferior parietal lobule arteriovenous malformations: a combined fMRI and DTI study. J Neurosurg. 2020 Mar 20;134(3):953-960. doi: 10.3171/2019.12.JNS191987.
• Li M, Jiang P, Guo R, Liu Q, Yang S, Wu J, Cao Y, Wang S. A Tractography-Based Grading Scale of Brain Arteriovenous Malformations Close to the Corticospinal Tract to Predict Motor Outcome After Surgery. Front Neurol. 2019 Jul 17;10:761. doi: 10.3389/fneur.2019.00761. eCollection 2019.
• Tong X, Wu J, Cao Y, Zhao Y, Wang S. New predictive model for microsurgical outcome of intracranial arteriovenous malformations: study protocol. BMJ Open. 2017 Jan 27;7(1):e014063. doi: 10.1136/bmjopen-2016-014063.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 13, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 13, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: multimodal imaging; surgical risk; arteriovenous malformations
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: SCW2016-11-AVM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No