Cerebrovascular DiseasesNCT07845929
Clinical Application of a Low-Dose CBCT AI Model
A study testing DeepPriorCBCT-V2 and Clinical standard protocol (Full-radiation-dose CBCT) in people with Cerebrovascular Diseases and Lung, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 5 sites in China.
Trial summary
Cone Beam CT (CBCT) is an imaging modality used in interventional digital subtraction angiography (DSA). It produces three-dimensional images via cone-beam X-ray scanning and computer reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Diseases, Lung, Liver
- What is being tested?
- DeepPriorCBCT-V2 and Clinical standard protocol (Full-radiation-dose CBCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,380 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2026to 31 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Requires CBCT-guided interventional treatment or surgery (e.g., cerebral angiography, lung puncture biopsy, hepatic artery chemoembolization, or percutaneous liver biopsy) 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
- 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.
- ⑥ Participants are not suitable for the trial per investigator's opinion.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Tao Sun, 18064075705, 1393879727@qq.com
- Recruiting
Zhongda Hospital, Medical School, Southeast University
Nanjing, Jiangsu
Jian Lu, 15850654644, lujian43307131@126.com
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Lei Chen, 15971480677, chan0812@126.com
- Recruiting
Wuhan Union Jinyin Lake Hospital
Wuhan, Hubei, 430022
Lei Chen, 15971480677, chan0812@126.com
- Recruiting
Wuhan Union West Hospital
Wuhan, Hubei, 430022
Lei Chen, 15971480677, chan0812@126.com
About this study
Official title: Low-dose AI-reconstructed CBCT Versus Full-dose CBCT for Guidance of Interventional Procedures: a Multicenter Randomized Controlled Trial
Cone Beam CT (CBCT) is an imaging modality used in interventional digital subtraction angiography (DSA). It produces three-dimensional images via cone-beam X-ray scanning and computer reconstruction. Clinically, CBCT guides puncture for pulmonary and hepatic lesions and evaluates post-intervention outcomes in liver cancer and cerebrovascular diseases. However, CBCT-guided interventions carry high patient radiation exposure; dose reduction often degrades image quality and impairs procedural results. Studies report that each 100 mGy radiation increment elevates cancer risk by 1.96-fold.
Artificial intelligence enables low-dose CBCT. Our prior DeepPriorCBCT model embedded anatomical priors using neural discrete representation learning, reducing thoracic CBCT dose to one-sixth of routine protocols while preserving image quality. We further developed DeepPriorCBCT-V2 using 55 000 pre-reconstruction CBCT datasets covering brain, thorax and abdomen. This multi-organ model maintains image quality at one-sixth standard radiation dose. Nevertheless, its real-world clinical performance remains unvalidated. We therefore designed this prospective multicenter randomized controlled trial to evaluate the clinical applicability of DeepPriorCBCT-V2.
- Conditions
- Cerebrovascular Diseases, Lung, Liver
- Being tested
- DeepPriorCBCT-V2, Clinical standard protocol (Full-radiation-dose CBCT)
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepPriorCBCT-V2Other
Compared with conventional CBCT-guided interventional procedures and previously reported low-dose CBCT studies, the intervention adopted in the present study has several distinct advantages. First, most existing low-dose CBCT protocols only reduce radiation for a single anatomical region, mainly the thorax, while our DeepPriorCBCT-V2 model achieves stable low-dose reconstruction for the brain, thorax, and abdomen simultaneously, with radiation reduced to 1/6 of the standard clinical level for the thorax and abdomen and 1/5 for the brain. Second, unlike general noise-reduction algorithms used in previous studies, our model embeds anatomical prior information through neural discrete representation learning, which ensures consistent and reliable image quality at extremely low radiation doses without sacrificing intraoperative guidance accuracy. Third, this study is the first prospective multicenter randomized controlled trial to systematically verify the clinical feasibility of multi-orga
Clinical standard protocol (Full-radiation-dose CBCT)Device
Interventional procedures were performed under the guidance of clinical standard protocol (Full-radiation-dose CBCT).
| Study group | Role | What they receive |
|---|---|---|
| Participants will receive interventional procedures guided by DeepPriorCBCT-V2. | Experimental | Patients underwent interventional procedures guided by CBCT images reconstructed via the DeepPriorCBCT-V2 model from low-radiation-dose scans (1/6 of the conventional dose for the thorax and abdomen, and 1/5 for the brain). Receives: Other: DeepPriorCBCT-V2 |
| Participants will receive interventional procedures guided by clinical standard protocol. | Placebo comparator | Patients underwent interventional procedures guided by CBCT images reconstructed via clinical standard protocol (full-radiation-dose). Receives: Device: Clinical standard protocol (Full-radiation-dose CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose
Air Kerma (AK) refers to the sum of the initial kinetic energies transferred from uncharged ionizing radiation (such as X-ray photons) to charged particles in air, divided by the mass of air at that location.
Measured: Through study completion, an average of 5 months.
Secondary outcomes (3)
Operation time
The time from the initiation to the completion of the interventional procedure.
Measured: Through study completion, an average of 5 months.
Intraoperative complications.
Procedure-related intraprocedural complications.
Measured: Through study completion, an average of 5 months.
Post operative complications
Procedure-related complications within 7 days after the interventional procedure.
Measured: Through study completion, an average of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845929
- Sponsor's protocol ID
- DeepPriorCBCT-V2
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose AI-reconstructed CBCT Versus Full-dose CBCT for Guidance of Interventional Procedures: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845929
- Acronym / sponsor ID
- DeepPriorCBCT-V2
- Conditions
- Cerebrovascular Diseases, Lung, Liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (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.
Cone Beam CT (CBCT) is an imaging modality used in interventional digital subtraction angiography (DSA). It produces three-dimensional images via cone-beam X-ray scanning and computer reconstruction. Clinically, CBCT guides puncture for pulmonary and hepatic lesions and evaluates post-intervention outcomes in liver cancer and cerebrovascular diseases. However, CBCT-guided interventions carry high patient radiation exposure; dose reduction often degrades image quality and impairs procedural results. Studies report that each 100 mGy radiation increment elevates cancer risk by 1.96-fold.
Artificial intelligence enables low-dose CBCT. Our prior DeepPriorCBCT model embedded anatomical priors using neural discrete representation learning, reducing thoracic CBCT dose to one-sixth of routine protocols while preserving image quality. We further developed DeepPriorCBCT-V2 using 55 000 pre-reconstruction CBCT datasets covering brain, thorax and abdomen. This multi-organ model maintains image quality at one-sixth standard radiation dose. Nevertheless, its real-world clinical performance remains unvalidated. We therefore designed this prospective multicenter randomized controlled trial to evaluate the clinical applicability of DeepPriorCBCT-V2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will receive interventional procedures guided by DeepPriorCBCT-V2. | Experimental | Other: DeepPriorCBCT-V2Patients underwent interventional procedures guided by CBCT images reconstructed via the DeepPriorCBCT-V2 model from low-radiation-dose scans (1/6 of the conventional dose for the thorax and abdomen, and 1/5 for the brain). |
| Participants will receive interventional procedures guided by clinical standard protocol. | Placebo comparator | Device: Clinical standard protocol (Full-radiation-dose CBCT)Patients underwent interventional procedures guided by CBCT images reconstructed via clinical standard protocol (full-radiation-dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
Key exclusion criteria (6 listed)
- History of high-dose radiation exams or treatments.
- ⑥ Participants are not suitable for the trial per investigator's opinion.
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 |
|---|---|---|
| DeepPriorCBCT-V2Compared with conventional CBCT-guided interventional procedures and previously reported low-dose CBCT studies, the intervention adopted in the present study has several distinct advantages. First, most existing low-dose CBCT protocols only reduce radiation for a single anatomical region, mainly the thorax, while our DeepPriorCBCT-V2 model achieves stable low-dose reconstruction for the brain, thorax, and abdomen simultaneously, with radiation reduced to 1/6 of the standard clinical level for the thorax and abdomen and 1/5 for the brain. Second, unlike general noise-reduction algorithms used in previous studies, our model embeds anatomical prior information through neural discrete representation learning, which ensures consistent and reliable image quality at extremely low radiation doses without sacrificing intraoperative guidance accuracy. Third, this study is the first prospective multicenter randomized controlled trial to systematically verify the clinical feasibility of multi-orga | Other | Participants will receive interventional procedures guided by DeepPriorCBCT-V2. |
| Clinical standard protocol (Full-radiation-dose CBCT)Interventional procedures were performed under the guidance of clinical standard protocol (Full-radiation-dose CBCT). | Device | Participants will receive interventional procedures guided by clinical standard protocol. |
Primary outcome
Radiation dose
Time frame: Through study completion, an average of 5 months.
Air Kerma (AK) refers to the sum of the initial kinetic energies transferred from uncharged ionizing radiation (such as X-ray photons) to charged particles in air, divided by the mass of air at that location.
3 secondary outcomes
Operation time
Time frame: Through study completion, an average of 5 months.
Intraoperative complications.
Time frame: Through study completion, an average of 5 months.
Post operative complications
Time frame: Through study completion, an average of 5 months.
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 29 Sep 2026.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeepPriorCBCT-V2 and Clinical standard protocol (Full-radiation-dose CBCT) in people with Cerebrovascular Diseases and Lung, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 5 sites 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Lei Chen (15971480677, chan0812@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose (time frame: Through study completion, an average of 5 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.