- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05614193
Deep Enhanced Imaging in Stroke and Vascular Neurology
February 7, 2023 updated by: Xin Lou, Chinese PLA General Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients have experienced stroke or cerebral ischemia and undergone brain imaging and vascular imaging.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Imaging group
Participants with suspecting brain stroke or vascular lesion conducted conventional CT or MR imaging and deep enhanced imaging.
|
Conventional imaging or down-sampling imaging from CT or MR are enhanced by approved deep learning method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The performance of deep enhanced imaging in lesion detection and diagnosis
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2022
Primary Completion (ANTICIPATED)
December 31, 2027
Study Completion (ANTICIPATED)
December 31, 2027
Study Registration Dates
First Submitted
November 5, 2022
First Submitted That Met QC Criteria
November 5, 2022
First Posted (ACTUAL)
November 14, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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