Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02868008
Acronym
MITASREAVM
Enrollment
400
Registered
2016-08-16
Start date
2016-06-30
Completion date
2019-12-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Arteriovenous Malformations

Keywords

multimodal imaging, surgical risk, 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 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.

Interventions

PROCEDUREMicrosurgical resection of brain AVMs

fMRI guided microsurgical resection of brain AVMs

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
Xuanwu Hospital, Beijing
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
neurologic status measured by modified Rankin scale scoresix months after AVM surgerythe changes of modified Rankin scale (mRS) score six months after AVM surgery compared with the presurgical mRS score

Secondary

MeasureTime frameDescription
AVM obliteration confirmed by postoperative DSA or CTAwithin one week after surgeryAVM obliteration on DSA or CTA
AVM rebleeding confirmed by CT scanwithin 6 months after surgeryAVM rebleeding confirmed by CT scan within 6 months after surgery
Seizure control measured by Engel classificationwithin 6 months after surgerySeizure control or new seizure onset according to Engel classification within 6 months after surgery
number of patient deathswithin 6 months after surgerynumber of patient deaths due to AVM rebleeding or surgery
number of patients with aphasia6 months after surgerynumber of patients with aphasia measured by Western Aphasia Battery (WAB) 6 months after surgery
number of patients with visual field defect6 months after surgerynumber of patients with visual field defect measured by visual field testing 6 months after surgery
muscle strength measured by muscle strength grading scale6 months after surgerymuscle strength according to muscle strength grading scale 6 months after surgery

Countries

China

Contacts

Primary ContactYong Cao, M.D.
caoyong6@hotmail.com861067096510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026