AI-based Low Dose CBCT Reconstruction for Clinical Application

ConditionLung Nodule
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AI-based low dose CBCT reconstructed images system

    Other intervention

    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.

  • Conventional CBCT images system

    Other intervention

    Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: AI based CBCT reconstructed images guided lung punctureExperimental treatment 1 intervention
Group B: Conventional CBCT images guided lung puncturePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of the lung puncture procedure.

Secondary outcomes

1

Radiation Dose

Radiation dose was defined as the radiation dose generated throughout the percutaneous lung puncture procedure.

Time frame
From enrollment to the end of the lung puncture procedure.
2

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.

Time frame
From enrollment to the end of the lung puncture procedure at 1 week.

Other outcomes

1

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.

Time frame
Through study completion, an average of 9 months.
2

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.

Time frame
Through study completion, an average of 9 months.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: