Cerebrovascular Disease
Conditions
Keywords
Cerebrovascular, AI, 3D-DSA
Brief summary
If the participants agree to participate in this study, the participants will undergo two scans (classic 3D-DSA and PS-3D-DSA assisted scan) to compare the imaging effects of both. After the procedure, the investigators will record the radiation exposure and collect DSA images.
Detailed description
Although several previous studies have used deep learning methods to reduce 3D-DSA radiation dose, no prospective clinical trial had yet validated the practical application of these models. Herein, the investigators introduce a patient-specific generative AI-based low-dose cerebrovascular 3D-DSA image reconstruction method (PS-3D-DSA) to reconstruct 3D-DSA images from ultra-sparse 2D projection views and a prospective cohort is used to validate its efficacy in clinical practice.
Interventions
RADIATIONPS-3D-DSA
undergo a PS-3D-DSA scan
RADIATIONclassic 3D-DSA
undergo a classic 3D-DSA scan
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years. 2. Requires 3D-DSA-guided interventional diagnosis or treatment (e.g., cerebral angiography, cerebral artery chemoembolization) and meets operational indications. 3. Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.
Exclusion criteria
1. Severe heart or lung disease, such as heart failure or chronic obstructive pulmonary disease (COPD). 2. History of high-dose radiation exams or treatments. 3. Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications. 4. Pregnant or breastfeeding women. 5. Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency). 6. Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA) | No more than 6 hours | Using the built-in radiation monitoring function of interventional surgical equipment (DSA system), the radiation dose (AK，air kerma) received by the patient during the procedure is directly measured and recorded. The collected radiation dose data is documented in the patient's medical records and stored in the research database for subsequent analysis and comparative studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA) | No more than 1 month | The secondary outcomes focus on evaluating the performance of interventional radiologists using either PS-3D-DSA or classic 3D-DSA for diagnostic tasks, with accuracy as the primary measure. Specifically, the diagnostic results from multiple radiologists will be compared against the gold standard to determine the level of agreement and diagnostic accuracy. This comparison will involve calculating sensitivity, specificity, and overall accuracy. Furthermore, receiver operating characteristic (ROC) curves will be plotted to assess the diagnostic performance and to visually represent the trade-off between sensitivity and specificity for each method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of image quality using two scanning protocols (classic 3D-DSA and PS-3D-DSA) | No more than 1 month | Algorithmic performance for image quality and interventional radiologists' scoring of image. Specifically, multiple radiologists will provide subjective ratings of image quality, with the best quality rated as 5 and the worst as 1. Image Quality (5 points): 1. point: The smoothness of the video is very poor, with noticeable stuttering in the animation, making it nearly impossible to provide a smooth viewing experience. 2. points: The smoothness of the video is poor, with a delayed animation, resulting in a less-than-ideal viewing experience. 3. points: The smoothness of the video is average, the animation is relatively smooth, offering a satisfactory viewing experience. 4. points: The smoothness of the video is high, with smooth and natural animation, providing an excellent viewing experience. 5. points: The smoothness of the video is extremely high, with exceptionally smooth animation, providing an outstanding viewing experience. |
Countries
China
Contacts
Primary ContactHuangxuan Zhao, PhD
Outcome results
None listed