Functional Innovation and Application Research of Domestic Advanced Low-Dose DSA/CT-DSA

July 17, 2025 updated by: Wuhan Union Hospital, China

Enhancing CBCT-Guided Lung Nodule Puncture Efficiency With Generative AI

The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:

  • Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
  • Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture.

Participants will:

  • Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
  • The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
  • The images of CBCT will be collected

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

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 Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Jinyinhu Hospital
      • Wuhan, Hubei, China, 430022
        • Wuhan Union West Hospital

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 with pre-operation CT images available.
  • Participants whose physical condition is suitable for PLP.

Exclusion Criteria:

  • Participants have metallic implants in the body, which severely affects the image quality.
  • Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
  • 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GPS guided lung puncture
Participants will receive percutaneous lung puncture under the guidance of GPS.
Combination product: Generative AI Based Puncture Surgery Navigation System
Participants will receive percutaneous lung puncture under the guidance of GPS.
Placebo Comparator: CBCT guided lung puncture
Participants will receive percutaneous lung puncture under the guidance of cone beam CT.
Device: Cone beam CT
Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of puncture needles of participants for GPS and CBCT-guided 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 for GPS and CBCT-guided lung puncture procedures.
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.
Puncture time for GPS and CBCT-guided lung puncture procedures.
Time Frame: From enrollment to the end of the lung puncture procedure.
Puncture time was defined as the duration of the entire percutaneous lung puncture procedure.
From enrollment to the end of the lung puncture procedure.
Intraoperative and postoperative complications of participants for GPS and CBCT-guided 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 three 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 three months.
Algorithmic performance (structural similarity)
Time Frame: Through study completion, an average of 3 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 3 months.
Doctors' scoring of image and lesion quality
Time Frame: Through study completion, an average of 3 months.
Doctors' scoring of image and lesion quality were got based on the 5-point scale Likert (1-5 points). Rated 5 out of 5 for very good images, 4 out of 5 for good, 3 out of 5 for moderate, 2 out of 5 for poor, 1 out of 5 for very poor.
Through study completion, an average of 3 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 (Actual)

January 1, 2025

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

June 18, 2025

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GPS-lung001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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