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RECRUITING
NCT07845929
NA

Clinical Application of a Low-Dose CBCT AI Model

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

View on ClinicalTrials.gov

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.

Official title: Low-dose AI-reconstructed CBCT Versus Full-dose CBCT for Guidance of Interventional Procedures: a Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1380

Start Date

2026-08-01

Completion Date

2026-12-31

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

OTHER

DeepPriorCBCT-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

DEVICE

Clinical standard protocol (Full-radiation-dose CBCT)

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

Locations (5)

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