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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPS guided lung puncture | Experimental | Participants will receive percutaneous lung puncture under the guidance of GPS. |
|
| CBCT guided lung puncture | Placebo Comparator | Participants will receive percutaneous lung puncture under the guidance of cone beam CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generative AI Based Puncture Surgery Navigation System | Combination Product | Participants will receive percutaneous lung puncture under the guidance of GPS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the lung puncture procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the lung puncture procedure. |
| Puncture time for GPS and CBCT-guided lung puncture procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China | ||
| Wuhan Union Jinyinhu Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37244147 | Result | 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. | |
| 35227506 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2025 | Jul 13, 2025 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2025 | Jul 13, 2025 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2024 | Dec 19, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D054893 | Cone-Beam Computed Tomography |
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014056 | Tomography, X-Ray |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| Cone beam CT | Device | Participants will receive percutaneous lung puncture under the guidance of cone beam CT. |
|
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. | 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. |
| Through study completion, an average of three months. |
| 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. | Through study completion, an average of 3 months. |
| 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. | Through study completion, an average of 3 months. |
| Wuhan |
| Hubei |
| 430022 |
| China |
| Wuhan Union West Hospital | Wuhan | Hubei | 430022 | China |
| 22976917 | Result | 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. |
| 26045345 | Result | 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. |
| 36920066 | Result | 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. |
| 35040882 | Result | 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. |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |