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

Intracranial Arteriovenous Malformations Clinical Trial

— MITASREAVM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02868008
• Other study ID #: SCW2016-11-AVM
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 13, 2016
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, M.D.
• Phone: 861067096510
• Email: caoyong6[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

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

Intervention

Procedure:
• Microsurgical resection of brain AVMs
fMRI guided microsurgical resection of brain AVMs

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Friendship Hospital, Beijing Hospital, Chinese PLA General Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	number of patient deaths	number of patient deaths due to AVM rebleeding or surgery	within 6 months after surgery	No
Secondary	AVM obliteration confirmed by postoperative DSA or CTA	AVM obliteration on DSA or CTA	within one week after surgery	Yes
Secondary	AVM rebleeding confirmed by CT scan	AVM rebleeding confirmed by CT scan within 6 months after surgery	within 6 months after surgery	Yes
Secondary	Seizure control measured by Engel classification	Seizure control or new seizure onset according to Engel classification within 6 months after surgery	within 6 months after surgery	Yes
Secondary	muscle strength measured by muscle strength grading scale	muscle strength according to muscle strength grading scale 6 months after surgery	6 months after surgery	Yes
Secondary	number of patients with aphasia	number of patients with aphasia measured by Western Aphasia Battery (WAB) 6 months after surgery	6 months after surgery	Yes
Secondary	number of patients with visual field defect	number of patients with visual field defect measured by visual field testing 6 months after surgery	6 months after surgery	Yes