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NCT Number: NCT06831617

AI-based Low Dose CBCT Reconstruction for Clinical Application

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

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Key information

Conditions

Lung Nodule

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Union Hospital, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AI-based low dose CBCT reconstructed images system

Other

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

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

Primary outcomes

  1. Number of puncture needles of participants undergoing percutaneous lung puncture procedures.

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

    The number of punctures was defined as the number of punctures performed throughout the percutaneous lung puncture procedure.

Secondary outcomes

  1. Radiation Dose

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

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

  2. Intraoperative and postoperative complications of participants undergoing lung puncture procedures

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

    Intraoperative and postoperative complications were defined as those arising in parricipants during percutaneous lung puncture and within 7 days after puncture.

Other outcomes

  1. Algorithmic performance (peak signal-to-noise ratio)

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

    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.

  2. Algorithmic performance (structural similarity)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huangxuan Zhao, PhD

CONTACT

[email protected]

+8618971676985

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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