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ClinicalTrials.gov ID

NCT06831617

Lead Sponsor

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

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

400Estimated

Last Update Posted

Feb 18, 2025Actual

Start Date

Mar 1, 2025Estimated

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Nov 30, 2025Estimated

Official Title

AI-based Low Dose CBCT Reconstruction for Lung Puncture Guidance: A Multicenter Randomized Controlled Study

Brief Summary

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:

1. Does the AI-based low dose CBCT reconstruction model reconstruct high quality images?
2. Is it possible that low-dose CBCT reconstructed images can guide lung puncture procedures without compromising the efficiency of the procedure? Researchers will compare AI-based low dose CBCT reconstructed images to a placebo (conventional CBCT images) to see if AI-based low dose CBCT reconstructed image can guide lung puncture procedures without compromising the efficiency of the procedure.

Participants will:

1. Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images
2. Be followed up for 1 week postoperative to obtain patient complications

• Lung Nodule

• AI-based low dose CBCT reconstructed images system
• Conventional CBCT images system

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
• Participants whose physical condition is suitable for PLP.
• Participants are willing to sign informed consent.

Exclusion Criteria:

• Participants have metallic implants in the body, which severely affects the image quality.
• Participants are pregnant or breastfeeding.
• Participants are unwilling or unable to sign informed consent.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

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

chan0812@126.com86-15971480677

chan0812@126.com15971480677