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

NCT02868008 | Unknown DMC

• 1 other identifier: SCW2016-11-AVM
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Arteriovenous Malformations

Keywords

multimodal imaging; surgical risk; arteriovenous malformations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• number of patient deaths

  within 6 months after surgery

• AVM obliteration confirmed by postoperative DSA or CTA

  within one week after surgery

• AVM rebleeding confirmed by CT scan

  within 6 months after surgery

• Seizure control measured by Engel classification

  within 6 months after surgery

• muscle strength measured by muscle strength grading scale

  6 months after surgery

Study Arms (1)

fMRI guided AVM resection

EXPERIMENTAL

fMRI guided microsurgical resection of brain AVMs

Procedure: Microsurgical resection of brain AVMs

Interventions

Microsurgical resection of brain AVMs PROCEDURE

fMRI guided microsurgical resection of brain AVMs

fMRI guided AVM resection

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged between 12 and 60 years
• 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
• Patients with a definite diagnosis of AVM confirmed by preoperative digital subtraction angiography
• Patients opting for surgical management at the five centers in this study
• Patients without any interventional therapy (microsurgery, radiosurgery, endovascular embolization, or multimodality treatment) before admission to the five centers

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Chinese PLA General Hospital: collaborator
• Beijing Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (4)

• Wen Z, Zheng K, Guo S, Liu Y, Wang K, Liu Q, Wu J, Wang S. The difference of functional MR imaging in evaluating outcome of patients with diffuse and compact brain arteriovenous malformation. Neurosurg Rev. 2024 Jul 24;47(1):347. doi: 10.1007/s10143-024-02593-9.

  PMID: 39043982 DERIVED

• 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. Print 2021 Mar 1.

  PMID: 32197246 DERIVED

• 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.

  PMID: 31379715 DERIVED

• 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.

  PMID: 28132013 DERIVED

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shuo Wang, M.D.

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Yong Cao, M.D.

CONTACT

861067096510; caoyong6@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 16, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)