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RecruitingNCT07845929Updated Sep 29, 2026

Clinical Application of a Low-Dose CBCT AI Model

An interventional study of DeepPriorCBCT-V2 and Clinical standard protocol (Full-radiation-dose CBCT) in Cerebrovascular Diseases, Lung and Liver, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,380
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Cerebrovascular Diseases
  • Lung
  • Liver
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,380 participants (estimated)

Study arms

  • Experimental
    Participants will receive interventional procedures guided by DeepPriorCBCT-V2.

    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).

    Other: DeepPriorCBCT-V2

  • Placebo comparator
    Participants will receive interventional procedures guided by clinical standard protocol.

    Patients underwent interventional procedures guided by CBCT images reconstructed via clinical standard protocol (full-radiation-dose).

    Device: Clinical standard protocol (Full-radiation-dose CBCT)

Interventions

  • OtherDeepPriorCBCT-V2

    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

  • DeviceClinical standard protocol (Full-radiation-dose CBCT)

    Interventional procedures were performed under the guidance of clinical standard protocol (Full-radiation-dose CBCT).

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 5 months.

Secondary outcomes

  1. Operation time

    The time from the initiation to the completion of the interventional procedure.

    Time frame: Through study completion, an average of 5 months.

  2. Intraoperative complications.

    Procedure-related intraprocedural complications.

    Time frame: Through study completion, an average of 5 months.

  3. Post operative complications

    Procedure-related complications within 7 days after the interventional procedure.

    Time frame: Through study completion, an average of 5 months.

Other outcomes

  1. Subjective scoring

    Scoring of reconstructed CBCT images was performed by radiologists and interventional physicians using a 5-point Likert scale. The scale was defined as: 1 = very poor image quality; lesions cannot be assessed and the procedure cannot be guided; 2 = poor image quality; lesion assessment and procedure guidance are difficult; 3 = moderate image quality; lesion assessment is relatively difficult, but procedure guidance is feasible; 4 = good image quality; lesions can be assessed and procedure guidance is achievable; 5 = excellent image quality; lesion assessment is not compromised at all and procedure guidance is fully supported.

    Time frame: Through study completion, an average of 5 months.

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Study locations

5 of 5 sites recruiting
  • The First Affiliated Hospital of University of Science and Technology of China
    Hefei, Anhui, China
    Recruiting
  • Wuhan Union Hospital
    Wuhan, Hubei 430022, China
    Recruiting
  • Wuhan Union Jinyin Lake Hospital
    Wuhan, Hubei 430022, China
    Recruiting
  • Wuhan Union West Hospital
    Wuhan, Hubei 430022, China
    Recruiting
  • Zhongda Hospital, Medical School, Southeast University
    Nanjing, Jiangsu, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07845929
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Aug 1, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 29, 2026

Study contacts

Lei Chen
Contact
chan0812@126.com
15971480677

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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