AI-based Low Dose CBCT Reconstruction for Clinical Application

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Lung Nodule

Treatments: Other: AI-based low dose CBCT reconstructed images system; Other: Conventional CBCT images system

Study type: Interventional

Funder types: Other

Identifiers

NCT06831617

AI guidance-Lung 001

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

AI based CBCT reconstructed images guided lung puncture

Experimental group

Description:

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.

Treatment:

Other: AI-based low dose CBCT reconstructed images system

Conventional CBCT images guided lung puncture

Placebo Comparator group

Description:

Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.

Treatment:

Other: Conventional CBCT images system