Cerebrovascular DiseaseNCT06769867
(Withdrawal) AI-Based Low-Dose 3D-DSA Reconstruction
A study testing PS-3D-DSA and classic 3D-DSA in people with Cerebrovascular Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- PS-3D-DSA and classic 3D-DSA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Cerebrovascular Disease
- Being tested
- PS-3D-DSA, classic 3D-DSA
- Keywords
- Cerebrovascular, AI, 3D-DSA
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS-3D-DSARadiation
undergo a PS-3D-DSA scan
classic 3D-DSARadiation
undergo a classic 3D-DSA scan
| Study group | Role | What they receive |
|---|---|---|
| PS-3D-DSA | Experimental | undergo a PS-3D-DSA scan Receives: Radiation: PS-3D-DSA |
| classic 3D-DSA | Sham comparator | undergo a classic 3D-DSA scan Receives: Radiation: classic 3D-DSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The radiation dose received by patients during interventional procedures when using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
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.
Measured: No more than 6 hours
Secondary outcomes (1)
The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
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.
Measured: No more than 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaowei Bai, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769867
- Sponsor's protocol ID
- Patient-Specific Generative AI
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26553142Irfan 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.
PubMed 37556901
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06769867
- Acronym / sponsor ID
- Patient-Specific Generative AI
- Conditions
- Cerebrovascular Disease
- Keywords
- Cerebrovascular, AI, 3D-DSA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS-3D-DSA | Experimental | Radiation: PS-3D-DSAundergo a PS-3D-DSA scan |
| classic 3D-DSA | Sham comparator | Radiation: classic 3D-DSAundergo a classic 3D-DSA scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS-3D-DSAundergo a PS-3D-DSA scan | Radiation | PS-3D-DSA |
| classic 3D-DSAundergo a classic 3D-DSA scan | Radiation | classic 3D-DSA |
Primary outcome
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.
1 secondary outcome
The image diagnostic capabilities using two scanning protocols (classic 3D-DSA and PS-3D-DSA)
Time frame: No more than 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Results publication: PubMed 26553142van 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.
- Results publication: PubMed 37556901Irfan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS-3D-DSA and classic 3D-DSA in people with Cerebrovascular Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huangxuan Zhao, PhD (+86 18627162379, zhao_huangxuan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.