(Withdrawal) AI-Based Low-Dose 3D-DSA Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Cerebrovascular Disease

• Registration Number: NCT06769867
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Study Start: 2025-04-15
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China