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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05614193
Other study ID # AI-301
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date December 31, 2027

Study information

Verified date February 2023
Source Chinese PLA General Hospital
Contact Jinhao Lyu
Phone +8615903562929
Email 330322990@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the performance of enhanced computed tomography (CT) or magnetic resonance (MR) imaging by deep learning relative to conventional CT or MR imaging in brain stroke and vascular neurology. We expect that the deep enhanced imaging method can shorten the time stay in the imaging session of stroke patients, optimize the overall imaging quality and improve the patients' care in imaging session.


Description:

Early diagnosis of cerebral infarction, detection of ischemic penumbra, evaluation of collateral circulation and identification of vascular lesions by imaging are critical for treatment decision and outcome improvement in cerebral stroke. Multimodal computed tomography (CT) and magnetic resonance (MR) imaging are most prevalent and accessible approaches in clinical scenarios. These two approaches are downgraded either by radiation exposure or long scanning time which may hinder the rapid treatment for patients. Deep learning has shown substantial achievements in medical imaging enhancement. The added value of deep learning method in stroke and vascular neurology has not been thoroughly validated. In this study, we aimed to investigate the performance of enhanced computed tomography (CT) or magnetic resonance (MR) imaging by deep learning relative to conventional CT or MR imaging in brain stroke and vascular neurology. We expect that the deep enhanced imaging method can shorten the time stay in the imaging session of stroke patients, optimize the overall imaging quality and improve the patients' care in imaging session.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - suspecting to have experienced stroke or cerebral ischemia and needed to undergo brain imaging and vascular imaging including CT or MRI - no history of kidney failure - a minimum age of 18 years - obtained written informed consent Exclusion Criteria: - severe movement artifacts - incidental finding of tumor lesion or craniocerebral surgery history - poor imaging failed to perform deep learning method - women who pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Deep learning imaging enhancement
Conventional imaging or down-sampling imaging from CT or MR are enhanced by approved deep learning method.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The performance of deep enhanced imaging in lesion detection and diagnosis The performance of deep enhanced imaging in lesion detection and diagnosis, including imaging quality, accuracy, sensitivity and specificity in lesion detection and imaging diagnosis. 1 year
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