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

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ClinicalTrials.gov Identifier: NCT02868008
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
Chinese PLA General Hospital
Beijing Hospital
Xuanwu Hospital, Beijing
Beijing Friendship Hospital
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

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.

Condition or disease Intervention/treatment Phase
Intracranial Arteriovenous Malformations Procedure: Microsurgical resection of brain AVMs Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Multimodal Magnetic Resonance Imaging Techniques in Assessing the Surgical Risk for Eloquent Arteriovenous Malformations
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  1. neurologic status measured by modified Rankin scale score [ Time Frame: six months after AVM surgery ]
    the changes of modified Rankin scale (mRS) score six months after AVM surgery compared with the presurgical mRS score


Secondary Outcome Measures :
  1. number of patient deaths [ Time Frame: within 6 months after surgery ]
    number of patient deaths due to AVM rebleeding or surgery

  2. AVM obliteration confirmed by postoperative DSA or CTA [ Time Frame: within one week after surgery ]
    AVM obliteration on DSA or CTA

  3. AVM rebleeding confirmed by CT scan [ Time Frame: within 6 months after surgery ]
    AVM rebleeding confirmed by CT scan within 6 months after surgery

  4. Seizure control measured by Engel classification [ Time Frame: within 6 months after surgery ]
    Seizure control or new seizure onset according to Engel classification within 6 months after surgery

  5. muscle strength measured by muscle strength grading scale [ Time Frame: 6 months after surgery ]
    muscle strength according to muscle strength grading scale 6 months after surgery

  6. number of patients with aphasia [ Time Frame: 6 months after surgery ]
    number of patients with aphasia measured by Western Aphasia Battery (WAB) 6 months after surgery

  7. number of patients with visual field defect [ Time Frame: 6 months after surgery ]
    number of patients with visual field defect measured by visual field testing 6 months after surgery



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868008


Contacts
Contact: Yong Cao, M.D. 861067096510 ext 100050 caoyong6@hotmail.com

Locations
China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, M.D.    861067096510 ext 100050    caoyong6@hotmail.com   
Principal Investigator: Shuo Wang, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
Chinese PLA General Hospital
Beijing Hospital
Xuanwu Hospital, Beijing
Beijing Friendship Hospital
Investigators
Study Chair: Shuo Wang, M.D. Beijing Tiantan Hospital,Capital Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Yong Cao, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02868008     History of Changes
Other Study ID Numbers: SCW2016-11-AVM
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Yong Cao, Beijing Tiantan Hospital:
multimodal imaging
surgical risk
arteriovenous malformations

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Intracranial Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Central Nervous System Vascular Malformations
Nervous System Malformations
Hemangioma
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases