(Withdrawal) Validation of a Patient-Specific Generative AI-Based Low-Dose Cerebrovascular 3D-DSA Image Reconstruction Method: a Stepwise, Multicenter, Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years.
- •Requires 3D-DSA-guided interventional diagnosis or treatment (e.g., cerebral angiography, cerebral artery chemoembolization) and meets operational indications.
- •Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.
排除标准
- •Severe heart or lung disease, such as heart failure or chronic obstructive pulmonary disease (COPD).
- •History of high-dose radiation exams or treatments.
- •Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.
- •Pregnant or breastfeeding women.
- •Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency).
- •Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.
研究组 & 干预措施
PS-3D-DSA
undergo a PS-3D-DSA scan
干预措施: PS-3D-DSA (Radiation)
classic 3D-DSA
undergo a classic 3D-DSA scan
干预措施: classic 3D-DSA (Radiation)
结局指标
主要结局
The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
时间窗: 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.
次要结局
- The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)(No more than 1 month)
研究者
Yaowei Bai
MD
Huazhong University of Science and Technology