AI-based Low Dose CBCT Reconstruction for Clinical Application

February 12, 2025 updated by: Wuhan Union Hospital, China

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
        • Principal Investigator:
          • Bo Du, PhD
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Jinyinhu Hospital
        • Principal Investigator:
          • Bo Du, PhD
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Wuhan Union West Hospital
        • Principal Investigator:
          • Bo Du, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI based CBCT reconstructed images guided lung puncture
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: 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.
Placebo Comparator: Conventional CBCT images guided lung puncture
Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.
Other: Conventional CBCT images system
Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the lung puncture procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the lung puncture procedure.
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.
From enrollment to the end of the lung puncture procedure at 1 week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 9 months.
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.
Through study completion, an average of 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI guidance-Lung 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The anonymized data is available from Huangxuan Zhao upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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