Clinical Application of a Low-Dose CBCT AI Model
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
DeepPriorCBCT-V2
Other interventionCompared 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)
DeviceInterventional procedures were performed under the guidance of clinical standard protocol (Full-radiation-dose CBCT).
Treatment groups
1,380 Participants
are divided into 2 treatment groupsGroup A: Participants will receive interventional procedures guided by DeepPriorCBCT-V2.Experimental treatment 1 intervention
Group B: Participants will receive interventional procedures guided by clinical standard protocol.Placebo comparator 1 intervention
Trial outcomes
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.Sponsors and contacts
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Source ClinicalTrials.gov