Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05449106 |
| Other study ID # |
KY2022-054-02 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2022 |
| Est. completion date |
May 25, 2032 |
Study information
| Verified date |
August 2023 |
| Source |
Beijing Tiantan Hospital |
| Contact |
Shaosen Zhang, Doctor |
| Phone |
+8618611284839 |
| Email |
longyoubafang[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
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.
