AI-based Low Dose CBCT Reconstruction for Clinical Application

NCT ID: NCT06831617

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-11-30

Brief Summary

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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:

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

Detailed Description

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Conditions

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Lung Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AI based CBCT reconstructed images guided lung puncture

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.

Group Type EXPERIMENTAL

AI-based low dose CBCT reconstructed images system

Intervention Type 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.

Conventional CBCT images guided lung puncture

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

Group Type PLACEBO_COMPARATOR

Conventional CBCT images system

Intervention Type OTHER

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

Interventions

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AI-based low dose CBCT reconstructed images system

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.

Intervention Type OTHER

Conventional CBCT images system

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wuhan Union Hospital

Wuhan, Hubei, China

Site Status

Wuhan Union Jinyinhu Hospital

Wuhan, Hubei, China

Site Status

Wuhan Union West Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Huangxuan Zhao, PhD

Role: CONTACT

+8618971676985

Facility Contacts

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Lei Chen, MD

Role: primary

86-15971480677

Lei Chen, MD

Role: primary

86-15971480677

Lei Chen, MD

Role: primary

15971480677

References

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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.

Reference Type RESULT
PMID: 39163857 (View on PubMed)

Other Identifiers

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AI guidance-Lung 001

Identifier Type: -

Identifier Source: org_study_id

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