Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:30 PM
Study NCT ID:
NCT06769867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(Withdrawal) AI-Based Low-Dose 3D-DSA Reconstruction
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
(Withdrawal) Validation of a Patient-Specific Generative AI-Based Low-Dose Cerebrovascular 3D-DSA Image Reconstruction Method: a Stepwise, Multicenter, Randomized Crossover Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: