Clinical trial NCT06769867: (Withdrawal) AI-Based Low-Dose 3D-DSA Reconstruction
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebrovascular Disease
Keywords: Cerebrovascular
AI
3D-DSA
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
timeFrame: No more than 6 hours
Secondary outcomes:
measure: The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
timeFrame: No more than 1 month
Other outcomes:
measure: Comparison of image quality using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
timeFrame: No more than 1 month
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
citation: van Asch CJ, Velthuis BK, Rinkel GJ, Algra A, de Kort GA, Witkamp TD, de Ridder JC, van Nieuwenhuizen KM, de Leeuw FE, Schonewille WJ, de Kort PL, Dippel DW, Raaymakers TW, Hofmeijer J, Wermer MJ, Kerkhoff H, Jellema K, Bronner IM, Remmers MJ, Bienfait HP, Witjes RJ, Greving JP, Klijn CJ; DIAGRAM Investigators. Diagnostic yield and accuracy of CT angiography, MR angiography, and digital subtraction angiography for detection of macrovascular causes of intracerebral haemorrhage: prospective, multicentre cohort study. BMJ. 2015 Nov 9;351:h5762. doi: 10.1136/bmj.h5762.
citation: Irfan M, Malik KM, Ahmad J, Malik G. StrokeNet: An automated approach for segmentation and rupture risk prediction of intracranial aneurysm. Comput Med Imaging Graph. 2023 Sep;108:102271. doi: 10.1016/j.compmedimag.2023.102271. Epub 2023 Jul 22.