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

Intracranial Arteriovenous Malformations Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

• NCT number: NCT02868008
• Study type: Interventional
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, M.D.
• Phone: 861067096510
• Email: caoyong6@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Completion date: December 2019