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NCT Number: NCT06769867

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

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.

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Key information

Conditions

Cerebrovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PS-3D-DSA

Radiation

undergo a PS-3D-DSA scan

classic 3D-DSA

Radiation

undergo a classic 3D-DSA scan

Primary outcomes

  1. The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

    Time frame: 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 outcomes

  1. The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

    Time frame: 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 outcomes

  1. Comparison of image quality using two scanning protocols (classic 3D-DSA and PS-3D-DSA)

    Time frame: 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):

    • 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.
    • points: The smoothness of the video is poor, with a delayed animation, resulting in a less-than-ideal viewing experience.
    • points: The smoothness of the video is average, the animation is relatively smooth, offering a satisfactory viewing experience.
    • points: The smoothness of the video is high, with smooth and natural animation, providing an excellent viewing experience.
    • points: The smoothness of the video is extremely high, with exceptionally smooth animation, providing an outstanding viewing experience.

Study contacts

Contact information is provided by the study sponsor or research team.

Huangxuan Zhao, PhD

CONTACT

[email protected]

+86 18627162379

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

(Withdrawal) Validation of a Patient-Specific Generative AI-Based Low-Dose Cerebrovascular 3D-DSA Image Reconstruction Method: A Stepwise, Multicenter, Randomized Crossover Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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