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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI based CBCT reconstructed images guided lung puncture | Experimental | 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. |
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| Conventional CBCT images guided lung puncture | Placebo Comparator | Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of puncture needles of participants undergoing percutaneous 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 | 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 |
| 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huangxuan Zhao, PhD | Contact | +8618971676985 | zhao_huangxuan@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39163857 | Result | Zhao H, Xu Z, Chen L, Wu L, Cui Z, Ma J, Sun T, Lei Y, Wang N, Hu H, Tan Y, Lu W, Yang W, Liao K, Teng G, Liang X, Li Y, Feng C, Nie T, Han X, Xiang D, Majoie CBLM, van Zwam WH, van der Lugt A, van der Sluijs PM, van Walsum T, Feng Y, Liu G, Huang Y, Liu W, Kan X, Su R, Zhang W, Wang X, Zheng C. Large-scale pretrained frame generative model enables real-time low-dose DSA imaging: An AI system development and multi-center validation study. Med. 2025 Jan 10;6(1):100497. doi: 10.1016/j.medj.2024.07.025. Epub 2024 Aug 19. |
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The anonymized data is available from Huangxuan Zhao upon reasonable request.
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| Conventional CBCT images system | Other | Participants in the experimental group undergo conventional CBCT images 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 9 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 9 months. |
| Wuhan Union Jinyinhu Hospital | Wuhan | Hubei | 430022 | China |
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| Wuhan Union West Hospital | Wuhan | Hubei | 430022 | China |
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