About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
Participants whose physical condition is suitable for PLP.
Participants are willing to sign informed consent.
Disqualifiers
Participants have metallic implants in the body, which severely affects the image quality.
Participants are pregnant or breastfeeding.
Participants are unwilling or unable to sign informed consent.
Trial design
Parallel
Treatments tested in this trial
AI-based low dose CBCT reconstructed images system
Other interventionParticipants 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.
Conventional CBCT images system
Other interventionParticipants in the experimental group undergo conventional CBCT images guided lung puncture procedures.
Treatment groups
Trial outcomes
Primary outcomes
Number of puncture needles of participants undergoing percutaneous lung puncture procedures.
The number of punctures was defined as the number of punctures performed throughout the percutaneous lung puncture procedure.
Secondary outcomes
Radiation Dose
Radiation dose was defined as the radiation dose generated throughout the percutaneous lung puncture procedure.
Intraoperative and postoperative complications of participants undergoing lung puncture procedures
Intraoperative and postoperative complications were defined as those arising in parricipants during percutaneous lung puncture and within 7 days after puncture.
Other outcomes
Algorithmic performance (peak signal-to-noise ratio)
Peak signal-to-noise ratio (PSNR) is a metric used to measure the quality of an image or video, assessing the degree of distortion by comparing the peak signal power to the mean square error (MSE) between the original signal and the compressed or processed signal. PSNR is measured in decibels (dB), with higher values indicating less distortion and better image or video quality.
Algorithmic performance (structural similarity)
Structural similarity (SSIM) is a metric for evaluating the similarity of two images. SSIM value is between 0 and 1, the larger the value, the more similar the images are.
Sponsors and contacts
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