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RECRUITING Not applicable ClinicalTrials.gov

Clinical Application of a Low-Dose CBCT AI Model

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology • ClinicalTrials.gov ID: NCT07845929

Registry updated: 2026-09-29
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Description

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.

Interventions

  • DeepPriorCBCT-V2 (Other)
    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).

Eligibility criteria

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: * 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.

Conditions

Cerebrovascular Diseases Lung Liver

Locations

  • The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China
  • Wuhan Union Hospital — Wuhan, Hubei, China
  • Wuhan Union Jinyin Lake Hospital — Wuhan, Hubei, China
  • Wuhan Union West Hospital — Wuhan, Hubei, China
  • Zhongda Hospital, Medical School, Southeast University — Nanjing, Jiangsu, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record