Lung NoduleNCT06831617
AI-based Low Dose CBCT Reconstruction for Clinical Application
A study testing AI-based low dose CBCT reconstructed images system and Conventional CBCT images system in people with Lung Nodule, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Nodule
- What is being tested?
- AI-based low dose CBCT reconstructed images system and Conventional CBCT images system
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Wuhan Union Hospital
Wuhan, Hubei, 430022
Lei Chen, MD, 86-15971480677, chan0812@126.com
Bo Du, PhD
Wuhan Union Jinyinhu Hospital
Wuhan, Hubei, 430022
Lei Chen, MD, 86-15971480677, chan0812@126.com
Bo Du, PhD
Wuhan Union West Hospital
Wuhan, Hubei, 430022
Lei Chen, MD, 15971480677, chan0812@126.com
Bo Du, PhD
About this study
Official title: AI-based Low Dose CBCT Reconstruction for Lung Puncture Guidance: A Multicenter Randomized Controlled Study
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:
- Does the AI-based low dose CBCT reconstruction model reconstruct high quality images?
- 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.
Read more
Participants will:
- Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images
- Be followed up for 1 week postoperative to obtain patient complications
- Conditions
- Lung Nodule
- Being tested
- AI-based low dose CBCT reconstructed images system, Conventional CBCT images system
- Keywords
- Artificial Intelligence, Lung Nodule, Cone Beam CT, Lung Puncture, Images Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based low dose CBCT reconstructed images systemOther
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 systemOther
Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AI-based low dose CBCT reconstructed images system |
| Conventional CBCT images guided lung puncture | Placebo comparator | Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures. Receives: Other: Conventional CBCT images system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the lung puncture procedure.
Secondary outcomes (2)
Radiation Dose
Radiation dose was defined as the radiation dose generated throughout the percutaneous lung puncture procedure.
Measured: From enrollment to the end of the lung puncture procedure.
Intraoperative and postoperative complications of participants undergoing lung puncture procedures
Intraoperative and postoperative complications were defined as those arising in parricipants during percutaneous lung puncture and within 7 days after puncture.
Measured: From enrollment to the end of the lung puncture procedure at 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831617
- Sponsor's protocol ID
- AI guidance-Lung 001
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The anonymized data is available from Huangxuan Zhao upon reasonable request.
Publications
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.
PubMed 39163857
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-based Low Dose CBCT Reconstruction for Lung Puncture Guidance: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06831617
- Acronym / sponsor ID
- AI guidance-Lung 001
- Conditions
- Lung Nodule
- Keywords
- Artificial Intelligence, Lung Nodule, Cone Beam CT, Lung Puncture, Images Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the AI-based low dose CBCT reconstruction model reconstruct high quality images?
- 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:
- Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images
- Be followed up for 1 week postoperative to obtain patient complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI based CBCT reconstructed images guided lung puncture | Experimental | Other: AI-based low dose CBCT reconstructed images systemParticipants 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 | Placebo comparator | Other: Conventional CBCT images systemParticipants in the experimental group undergo conventional CBCT images guided lung puncture procedures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based low dose CBCT reconstructed images systemParticipants 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. | Other | AI based CBCT reconstructed images guided lung puncture |
| Conventional CBCT images systemParticipants in the experimental group undergo conventional CBCT images guided lung puncture procedures. | Other | Conventional CBCT images guided lung puncture |
Primary outcome
Number of puncture needles of participants undergoing percutaneous lung puncture procedures.
Time frame: From enrollment to the end of the lung puncture procedure.
The number of punctures was defined as the number of punctures performed throughout the percutaneous lung puncture procedure.
2 secondary outcomes
Radiation Dose
Time frame: From enrollment to the end of the lung puncture procedure.
Intraoperative and postoperative complications of participants undergoing lung puncture procedures
Time frame: From enrollment to the end of the lung puncture procedure at 1 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Results publication: PubMed 39163857Zhao 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.
- Individual participant dataSharing planned: No. The anonymized data is available from Huangxuan Zhao upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based low dose CBCT reconstructed images system and Conventional CBCT images system in people with Lung Nodule, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huangxuan Zhao, PhD (+8618971676985, zhao_huangxuan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture needles of participants undergoing percutaneous lung puncture procedures. (time frame: From enrollment to the end of the lung puncture procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06831617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.