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Completed

NCT Number: NCT07035977

DeepPriorCBCT for Low Dose Lung CBCT Reconstruction

The goal of this clinical trial is to learn if the DeepPriorCBCT model ensure high-quality CBCT image while reducing CBCT radiation dose. The main questions it aims to answer are:

* Can DeepPriorCBCT reduce CBCT radiation doses? * Is the image quality of DeepPriorCBCT reconstruction consistent with that of existing clinical reconstruction method? Researchers will compare CBCT images quality reconstruction with DeepPriorCBCT model to CBCT image quality reconstruction with existing clinical protocols to see if DeepPriorCBCT model can improve the CBCT image quality while reducing radiation dose.

Participants will:

* Receive a single low dose (1/6 of existing clinical protocols) CBCT scan * Receive a single conventional dose CBCT scan

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Key information

Conditions

Lung Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital East Campus of Zhengzhou University, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will receive percutaneous thoracic puncture under the guidance of CBCT during the study period.
  • The participants' medical records containing basic information, medical history, etc are complete.
  • Participants can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.

Exclusion criteria

  • Participants are under the age of 18.
  • Participants are suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
  • Participants are pregnant or breastfeeding women.
  • Participants are concurrent participating in other programs that affect the results of this study.

Treatment and study plan

Participants will receive a 1/6 views undersampling lung CBCT scan.

Radiation

Participants will receive a 1/6 views undersampling lung CBCT scan. And the CBCT images will be reconstructed by DeepPriorCBCT model for further analysis.

Primary outcomes

  1. CBCT Images Quality Score

    Time frame: No more than 1 week

    CBCT Images Quality Score was analyzed by 5 radiologists using 5-point Likert scale.

Secondary outcomes

  1. The scores of lesion diagnosis from 5 radiologists

    Time frame: No more than 1 week

    5 radiologists from 5 medical centers will be invited to diagnosis the lesion of fully sampled machine-reconstructed CBCT images vs. undersampled model-reconstructed CBCT images.

  2. The agreement scores given by the 25 interventionalists.

    Time frame: No more than 1 week.

    25 interventionalists from 5 medical centers will be invited to analyze fully sampled machine-reconstructed CBCT images vs. undersampled model-reconstructed CBCT images. The scores given by the 25 interventionalists will be used for agreement score analysis.

  3. Radiation dose

    Time frame: No more than 1 day

    Radiation dose is defined as the radiation dose received by patients when undergoing one conventional-dose CBCT scan and one undersampled CBCT scan.

Other outcomes

  1. Objective indicators for reconstructed CBCT images

    Time frame: No more than 1 week.

    Objective indicators for reconstructed CBCT images include peak signal to noise ratio (PSNR) and structure similarity (SSIM). PSNR is a ratio that represents the ratio between the maximum possible power of a signal and the destructive noise power that affects its representation accuracy. SSIM is a metric for measuring image similarity.

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

A Deep-learning System for Low-Dose CBCT Image Reconstruction: a Stepwise, Multicentre, Early-stage Clinical Validation Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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