Clinical Application of a Low-Dose CBCT AI Model

NCT07845929 | Recruiting DMC

• 1 other identifier: DeepPriorCBCT-V2
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cerebrovascular Diseases; Lung; Liver

Outcome Measures

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.

  Through study completion, an average of 5 months.

Secondary Outcomes (3)

• Operation time

  Through study completion, an average of 5 months.

• Intraoperative complications.

  Through study completion, an average of 5 months.

• Post operative complications

  Through study completion, an average of 5 months.

Other Outcomes (1)

• Subjective scoring

  Through study completion, an average of 5 months.

Study Arms (2)

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).

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).

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

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

Participants will receive interventional procedures guided by DeepPriorCBCT-V2.

Clinical standard protocol (Full-radiation-dose CBCT) DEVICE

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

Participants will receive interventional procedures guided by clinical standard protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

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

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Lei Chen

CONTACT

15971480677; chan0812@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)