NCT06831617

AI-based Low Dose CBCT Reconstruction for Clinical Application

AI-based Low Dose CBCT Reconstruction for Lung Puncture Guidance: A Multicenter Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if AI-based low dose CBCT reconstructed images can guide lung puncture effectively. The main questions it aims to answer are: 1. Does the AI-based low dose CBCT reconstruction model reconstruct high quality images? 2. Is it possible that low-dose CBCT reconstructed images can guide lung puncture procedures without compromising the efficiency of the procedure? Researchers will compare AI-based low dose CBCT reconstructed images to a placebo (conventional CBCT images) to see if AI-based low dose CBCT reconstructed image can guide lung puncture procedures without compromising the efficiency of the procedure. Participants will: 1. Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images 2. Be followed up for 1 week postoperative to obtain patient complications

Conditions

• Lung Nodule

Interventions

Type	Name	Description
OTHER	AI-based low dose CBCT reconstructed images system	Participants in the experimental group undergo AI-based low dose (radiation dose is 1/6th of the dose used in the clinic) CBCT reconstructed images guided lung puncture procedures.
OTHER	Conventional CBCT images system	Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2025-02-18
• Last updated: 2025-02-18

Locations

3 sites across 1 country: China