Clinical trial NCT05449106: Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT
Official title: Evaluation of Clinical Outcomes of Unruptured Brain Arteriovenous Malformations Treated With Medical Management Alone Based on Multimodal Computer Tomography: A Long-term Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Arteriovenous Malformations
Keywords: Unruptured arteriovenous malformations
Multimodal CT
Machine learning
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2022-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of AVM was confirmed with Digital Subtraction Angiography (DSA) , Magnetic Resonance Imaging(MRI), or Computed Tomography Angiography, eligible for enrollment criteria and have images that were acquired without any intervention.

Brief summary: The purpose of this study is to investigate the role of multimodal CT in evaluating and predicting different clinical outcomes in patients with unruptured brain arteriovenous malformations with medical management alone.

This study will be undertaken in the following aspects:

1. Morphological, structural and imaging histological signal analysis based on multimodal CT to explore the relationship between imaging features and different clinical outcomes of bAVMs.
2. Hemodynamic and flow pattern analysis of local and peripheral bAVMs based on multimodal CT to explore the association between blood flow features and different clinical outcomes.
3. Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes.

The obtained patient information includes: Baseline information, CT, MRI, DSA (Optional), and follow-up information. Follow-up will be undertaken at 6 months, 12 months, 24 months and 36 months after enrollment with the following primary observation.

Main observation endpoints:

1. Hemorrhage events associated with bAVMs
2. New epilepsy symptoms or exacerbations
3. New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc).

Detailed description: This study is a Long-term, multi-center, prospective registry study, and was supported by China National Key Research and Development Program Project No. 2021YFC2500502.

The purpose of this study is to investigate the role of multimodal Computer Tomography(CT) in evaluating and predicting different clinical outcomes in patients with unruptured brain arteriovenous malformations with medical management alone.

This study will be undertaken in the following aspects:

1. Morphological, structural and imaging histological signal analysis based on multimodal CT to study the relationship between imaging features and different clinical outcomes of bAVMs.
2. Hemodynamic and flow pattern analysis of local and peripheral bAVMs based on multimodal CT to explore the association between blood flow features and different clinical outcomes.
3. Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes.
4. To compare the efficacy of multimodal CT and MRI in evaluating the clinical outcomes of unruptured cerebral arteriovenous malformations.

The obtained patient information includes:

1. Baseline information
2. CT images: including non-contrast CT(NCCT), CT Angiography, CT perfusion
3. Magnetic Resonance Imaging(MRI): including T1-weighted image, T2-weighted image, T2-FLAIR, Time of Flight MR angiography(TOF-MRA), diffusion-weighted imaging(DWI), susceptibility weighted imaging(SWI)
4. Digital subtraction angiography(DSA, optional)
5. Follow-up information: follow-up will be undertaken at 6 months, 12 months, 24 months and 36 months after enrollment with the following primary observation.

Main observation endpoints:

1. Hemorrhage events associated with bAVMs, ensuring by CT scan;
2. New epilepsy symptoms or exacerbations, ensuring by consultation or EEG ;
3. New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc), ensuring by consultation, physical examination or any radiology examination.

Inclusion criteria

1. Patients with confirmed diagnosis of bAVMs in the cerebrum, basal ganglia, thalamus, corpus callosum, cerebellum and brainstem;
2. Patients with no history of previous bAVM related hemorrhage confirmed by CT examination, or have radiographic examination completed prior to the hemorrhage.
3. Patients with radiographic examinations before any treatment;

Exclusion criteria.

1. Patients with simple arteriovenous fistula;
2. Patients with combined dural arteriovenous fistula;
3. Arteriovenous malformations occurring in the spinal cord;
4. Pregnant patients were not included in this study.

Eligibility criteria: Inclusion Criteria:

1. Patients with confirmed diagnosis of brain arteriovenous malformations in the brain, basal ganglia, thalamus, corpus callosum, cerebellum and other locations.
2. Patients with no history of previous arteriovenous malformation-related hemorrhage and no arteriovenous malformation-related hemorrhage confirmed by CT examination.
3. Patients with Radiographic examinations completed without any treatment

Exclusion Criteria:

1. Patients with simple arteriovenous fistula.
2. Patients with combined dural arteriovenous fistulas.
3. Arteriovenous malformations occurring in the spinal cord.
4. Pregnant patients were not included in this study.

Primary outcomes:
measure: Number of participants with rupture events
timeFrame: 3 years after enrollment
measure: Number of participants with epilepsy Progression
timeFrame: 3 years after enrollment
measure: Number of participants with new onset neurological dysfunction
timeFrame: 3 years after enrollment
Secondary outcomes:
measure: Number of participants receiving treatment
timeFrame: 3 years after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Beijing Tiantan Hospital, Beijing Hospital
name: Dong Zhang, Doctor
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Shaosen Zhang, Doctor
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Guosheng Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yongbo Yang
role: PRINCIPAL_INVESTIGATOR
References: