Multimodal Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations (MITASREAVM)
Primary Purpose
Intracranial Arteriovenous Malformations
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microsurgical resection of brain AVMs
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Arteriovenous Malformations focused on measuring multimodal imaging, surgical risk, arteriovenous malformations
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fMRI guided AVM resection
Arm Description
fMRI guided microsurgical resection of brain AVMs
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
number of patient deaths
number of patient deaths due to AVM rebleeding or surgery
AVM obliteration confirmed by postoperative DSA or CTA
AVM obliteration on DSA or CTA
AVM rebleeding confirmed by CT scan
AVM rebleeding confirmed by CT scan 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
muscle strength measured by muscle strength grading scale
muscle strength according to muscle strength grading scale 6 months after surgery
number of patients with aphasia
number of patients with aphasia measured by Western Aphasia Battery (WAB) 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
Full Information
NCT ID
NCT02868008
First Posted
July 25, 2016
Last Updated
August 13, 2016
Sponsor
Beijing Tiantan Hospital
Collaborators
Chinese PLA General Hospital, Beijing Hospital, Xuanwu Hospital, Beijing, Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02868008
Brief Title
Multimodal Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations
Acronym
MITASREAVM
Official Title
The Efficacy of Multimodal Magnetic Resonance Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Chinese PLA General Hospital, Beijing Hospital, Xuanwu Hospital, Beijing, Beijing Friendship Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriovenous Malformations
Keywords
multimodal imaging, surgical risk, arteriovenous malformations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fMRI guided AVM resection
Arm Type
Experimental
Arm Description
fMRI guided microsurgical resection of brain AVMs
Intervention Type
Procedure
Intervention Name(s)
Microsurgical resection of brain AVMs
Intervention Description
fMRI guided microsurgical resection of brain AVMs
Primary Outcome Measure Information:
Title
neurologic status measured by modified Rankin scale score
Description
the changes of modified Rankin scale (mRS) score six months after AVM surgery compared with the presurgical mRS score
Time Frame
six months after AVM surgery
Secondary Outcome Measure Information:
Title
number of patient deaths
Description
number of patient deaths due to AVM rebleeding or surgery
Time Frame
within 6 months after surgery
Title
AVM obliteration confirmed by postoperative DSA or CTA
Description
AVM obliteration on DSA or CTA
Time Frame
within one week after surgery
Title
AVM rebleeding confirmed by CT scan
Description
AVM rebleeding confirmed by CT scan within 6 months after surgery
Time Frame
within 6 months after surgery
Title
Seizure control measured by Engel classification
Description
Seizure control or new seizure onset according to Engel classification within 6 months after surgery
Time Frame
within 6 months after surgery
Title
muscle strength measured by muscle strength grading scale
Description
muscle strength according to muscle strength grading scale 6 months after surgery
Time Frame
6 months after surgery
Title
number of patients with aphasia
Description
number of patients with aphasia measured by Western Aphasia Battery (WAB) 6 months after surgery
Time Frame
6 months after surgery
Title
number of patients with visual field defect
Description
number of patients with visual field defect measured by visual field testing 6 months after surgery
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, M.D.
Phone
861067096510
Ext
100050
Email
caoyong6@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo Wang, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.
Phone
861067096510
Ext
100050
Email
caoyong6@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shuo Wang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32197246
Citation
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.
Results Reference
derived
PubMed Identifier
31379715
Citation
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.
Results Reference
derived
PubMed Identifier
28132013
Citation
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.
Results Reference
derived
Learn more about this trial
Multimodal Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations
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