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CompletedNCT06762613Updated Jul 23, 2025

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

An interventional study of Generative AI Based Puncture Surgery Navigation System and Cone beam CT in Lung Nodules, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Completed at 3 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Lung Nodules

Keywords

  • Generative AI
  • Lung puncture
  • Cone beam CT
  • DSA
03

In context

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 162 studies on the registry; 131 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • 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

  • Placebo comparator
    CBCT guided lung puncture

    Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

    Device: Cone beam CT

Interventions

  • Combination productGenerative AI Based Puncture Surgery Navigation System

    Participants will receive percutaneous lung puncture under the guidance of GPS.

  • DeviceCone beam CT

    Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

06

What researchers measure

Primary outcomes

  1. Number of puncture needles of participants for GPS and CBCT-guided 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 for GPS and CBCT-guided lung puncture procedures.

    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. Puncture time for GPS and CBCT-guided lung puncture procedures.

    Puncture time was defined as the duration of the entire percutaneous lung puncture procedure.

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

  3. Intraoperative and postoperative complications of participants for GPS and CBCT-guided 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 three 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 3 months.

  3. Doctors' scoring of image and lesion quality

    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.

    Time frame: Through study completion, an average of 3 months.

07

Study locations

3 sites
  • Wuhan Union Hospital
    Wuhan, Hubei 430022, China
  • Wuhan Union Jinyinhu Hospital
    Wuhan, Hubei 430022, China
  • Wuhan Union West Hospital
    Wuhan, Hubei 430022, China
08

References and documents

Publications

  • Deng L, Ji Y, Huang S, Yang X, Wang J. Synthetic CT generation from CBCT using double-chain-CycleGAN. Comput Biol Med. 2023 Jul;161:106889. doi: 10.1016/j.compbiomed.2023.106889. Epub 2023 Apr 3. PubMed 37244147 ↗
  • Ren Q, Zhou Y, Yan M, Zheng C, Zhou G, Xia X. Imaging-guided percutaneous transthoracic needle biopsy of nodules in the lung base: fluoroscopy CT versus cone-beam CT. Clin Radiol. 2022 May;77(5):e394-e399. doi: 10.1016/j.crad.2022.02.005. Epub 2022 Feb 25. PubMed 35227506 ↗
  • Choo JY, Park CM, Lee NK, Lee SM, Lee HJ, Goo JM. Percutaneous transthoracic needle biopsy of small (</= 1 cm) lung nodules under C-arm cone-beam CT virtual navigation guidance. Eur Radiol. 2013 Mar;23(3):712-9. doi: 10.1007/s00330-012-2644-6. Epub 2012 Sep 14. PubMed 22976917 ↗
  • Rotolo N, Floridi C, Imperatori A, Fontana F, Ierardi AM, Mangini M, Arlant V, De Marchi G, Novario R, Dominioni L, Fugazzola C, Carrafiello G. Comparison of cone-beam CT-guided and CT fluoroscopy-guided transthoracic needle biopsy of lung nodules. Eur Radiol. 2016 Feb;26(2):381-9. doi: 10.1007/s00330-015-3861-6. Epub 2015 Jun 6. PubMed 26045345 ↗
  • Steiling K, Kathuria H, Echieh CP, Ost DE, Rivera MP, Begnaud A, Celedon JC, Charlot M, Dietrick F, Duma N, Fong KM, Ford JG, Gould MK, Holguin F, Perez-Stable EJ, Tanner NT, Thomson CC, Wiener RS, Wisnivesky J. Research Priorities for Interventions to Address Health Disparities in Lung Nodule Management: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Mar 15;207(6):e31-e46. doi: 10.1164/rccm.202212-2216ST. PubMed 36920066 ↗
  • Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287. PubMed 35040882 ↗

Study documents

  • Study protocol · Jun 17, 2025
  • Statistical analysis plan · Jun 17, 2025
  • Informed consent form · Dec 14, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06762613
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
Jan 1, 2025
Primary completion
Mar 31, 2025
Completion
Jun 18, 2025
Last update
Jul 23, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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