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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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.

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 m
Sponsor: Beijing Tiantan Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of patient deaths [ Time Frame: within 6 months after surgery ]
    number of patient deaths due to AVM rebleeding or surgery
  • AVM obliteration confirmed by postoperative DSA or CTA [ Time Frame: within one week after surgery ]
    AVM obliteration on DSA or CTA
  • AVM rebleeding confirmed by CT scan [ Time Frame: within 6 months after surgery ]
    AVM rebleeding confirmed by CT scan within 6 months after surgery
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Beijing Tiantan Hospital

Dates:
Date Received: July 25, 2016
Date Started: June 2016
Date Completion: December 2019
Last Updated: August 13, 2016
Last Verified: August 2016