Lung NodulesNCT06762613
Functional Innovation and Application Research of Domestic Advanced Low-Dose DSA/CT-DSA
A study testing Generative AI Based Puncture Surgery Navigation System and Cone beam CT in people with Lung Nodules, 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 Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Nodules
- What is being tested?
- Generative AI Based Puncture Surgery Navigation System and Cone beam CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2025to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 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 with pre-operation CT images available.
- Participants whose physical condition is suitable for PLP.
Who cannot join
- Participants have metallic implants in the body, which severely affects the image quality.
- Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
- Participants are pregnant or breastfeeding.
- Participants are unwilling or unable to sign informed consent.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Wuhan Union Hospital
Wuhan, Hubei, 430022
Wuhan Union Jinyinhu Hospital
Wuhan, Hubei, 430022
Wuhan Union West Hospital
Wuhan, Hubei, 430022
About this study
Official title: Enhancing CBCT-Guided Lung Nodule Puncture Efficiency With Generative AI
The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:
- Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
- Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture.
Read more
Participants will:
- Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
- The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
- The images of CBCT will be collected
- Conditions
- Lung Nodules
- Being tested
- Generative AI Based Puncture Surgery Navigation System, Cone beam CT
- Keywords
- Generative AI, Lung puncture, Cone beam CT, DSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generative AI Based Puncture Surgery Navigation SystemCombination product
Participants will receive percutaneous lung puncture under the guidance of GPS.
Cone beam CTDevice
Participants will receive percutaneous lung puncture under the guidance of cone beam CT.
| Study group | Role | What they receive |
|---|---|---|
| GPS guided lung puncture | Experimental | Participants will receive percutaneous lung puncture under the guidance of GPS. Receives: Combination Product: Generative AI Based Puncture Surgery Navigation System |
| CBCT guided lung puncture | Placebo comparator | Participants will receive percutaneous lung puncture under the guidance of cone beam CT. Receives: Device: Cone beam CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puncture needles of participants for GPS and CBCT-guided 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 (3)
Radiation dose for GPS and CBCT-guided lung puncture procedures.
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.
Puncture time for GPS and CBCT-guided lung puncture procedures.
Puncture time was defined as the duration of the entire percutaneous lung puncture procedure.
Measured: From enrollment to the end of the lung puncture procedure.
Intraoperative and postoperative complications of participants for GPS and CBCT-guided 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 posted7 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Mar 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung NodulesStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762613
- Sponsor's protocol ID
- GPS-lung001
- Status last verified
- Jul 2025
- First submitted
- 15 Dec 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng L, Ji Y, Huang S, Yang X, Wang J. Synthetic CT generation from CBCT using double-chain-CycleGAN. Comput Biol Med. 2023 Jul;161:106889. doi: 10.1016/j.compbiomed.2023.106889. Epub 2023 Apr 3.
PubMed 37244147Ren Q, Zhou Y, Yan M, Zheng C, Zhou G, Xia X. Imaging-guided percutaneous transthoracic needle biopsy of nodules in the lung base: fluoroscopy CT versus cone-beam CT. Clin Radiol. 2022 May;77(5):e394-e399. doi: 10.1016/j.crad.2022.02.005. Epub 2022 Feb 25.
PubMed 35227506Choo JY, Park CM, Lee NK, Lee SM, Lee HJ, Goo JM. Percutaneous transthoracic needle biopsy of small (</= 1 cm) lung nodules under C-arm cone-beam CT virtual navigation guidance. Eur Radiol. 2013 Mar;23(3):712-9. doi: 10.1007/s00330-012-2644-6. Epub 2012 Sep 14.
PubMed 22976917Rotolo N, Floridi C, Imperatori A, Fontana F, Ierardi AM, Mangini M, Arlant V, De Marchi G, Novario R, Dominioni L, Fugazzola C, Carrafiello G. Comparison of cone-beam CT-guided and CT fluoroscopy-guided transthoracic needle biopsy of lung nodules. Eur Radiol. 2016 Feb;26(2):381-9. doi: 10.1007/s00330-015-3861-6. Epub 2015 Jun 6.
PubMed 26045345Steiling K, Kathuria H, Echieh CP, Ost DE, Rivera MP, Begnaud A, Celedon JC, Charlot M, Dietrick F, Duma N, Fong KM, Ford JG, Gould MK, Holguin F, Perez-Stable EJ, Tanner NT, Thomson CC, Wiener RS, Wisnivesky J. Research Priorities for Interventions to Address Health Disparities in Lung Nodule Management: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Mar 15;207(6):e31-e46. doi: 10.1164/rccm.202212-2216ST.
PubMed 36920066Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
PubMed 35040882
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing CBCT-Guided Lung Nodule Puncture Efficiency With Generative AI
- ClinicalTrials.gov ID
- NCT06762613
- Acronym / sponsor ID
- GPS-lung001
- Conditions
- Lung Nodules
- Keywords
- Generative AI, Lung puncture, Cone beam CT, DSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 7 Jan 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 Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:
- Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
- Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture.
Participants will:
- Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
- The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
- The images of CBCT will be collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPS guided lung puncture | Experimental | Combination Product: Generative AI Based Puncture Surgery Navigation SystemParticipants will receive percutaneous lung puncture under the guidance of GPS. |
| CBCT guided lung puncture | Placebo comparator | Device: Cone beam CTParticipants will receive percutaneous lung puncture under the guidance of cone beam CT. |
Who may qualify
- Ages
- 18 to 85 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 with pre-operation CT images available.
- Participants whose physical condition is suitable for PLP.
Key exclusion criteria (4 listed)
- Participants have metallic implants in the body, which severely affects the image quality.
- Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
- 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 |
|---|---|---|
| Generative AI Based Puncture Surgery Navigation SystemParticipants will receive percutaneous lung puncture under the guidance of GPS. | Combination product | GPS guided lung puncture |
| Cone beam CTParticipants will receive percutaneous lung puncture under the guidance of cone beam CT. | Device | CBCT guided lung puncture |
Primary outcome
Number of puncture needles of participants for GPS and CBCT-guided 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.
3 secondary outcomes
Radiation dose for GPS and CBCT-guided lung puncture procedures.
Time frame: From enrollment to the end of the lung puncture procedure.
Puncture time for GPS and CBCT-guided lung puncture procedures.
Time frame: From enrollment to the end of the lung puncture procedure.
Intraoperative and postoperative complications of participants for GPS and CBCT-guided lung puncture procedures.
Time frame: From enrollment to the end of the lung puncture procedure at 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 37244147Deng L, Ji Y, Huang S, Yang X, Wang J. Synthetic CT generation from CBCT using double-chain-CycleGAN. Comput Biol Med. 2023 Jul;161:106889. doi: 10.1016/j.compbiomed.2023.106889. Epub 2023 Apr 3.
- Results publication: PubMed 35227506Ren Q, Zhou Y, Yan M, Zheng C, Zhou G, Xia X. Imaging-guided percutaneous transthoracic needle biopsy of nodules in the lung base: fluoroscopy CT versus cone-beam CT. Clin Radiol. 2022 May;77(5):e394-e399. doi: 10.1016/j.crad.2022.02.005. Epub 2022 Feb 25.
- Results publication: PubMed 22976917Choo JY, Park CM, Lee NK, Lee SM, Lee HJ, Goo JM. Percutaneous transthoracic needle biopsy of small (</= 1 cm) lung nodules under C-arm cone-beam CT virtual navigation guidance. Eur Radiol. 2013 Mar;23(3):712-9. doi: 10.1007/s00330-012-2644-6. Epub 2012 Sep 14.
- Results publication: PubMed 26045345Rotolo N, Floridi C, Imperatori A, Fontana F, Ierardi AM, Mangini M, Arlant V, De Marchi G, Novario R, Dominioni L, Fugazzola C, Carrafiello G. Comparison of cone-beam CT-guided and CT fluoroscopy-guided transthoracic needle biopsy of lung nodules. Eur Radiol. 2016 Feb;26(2):381-9. doi: 10.1007/s00330-015-3861-6. Epub 2015 Jun 6.
- Results publication: PubMed 36920066Steiling K, Kathuria H, Echieh CP, Ost DE, Rivera MP, Begnaud A, Celedon JC, Charlot M, Dietrick F, Duma N, Fong KM, Ford JG, Gould MK, Holguin F, Perez-Stable EJ, Tanner NT, Thomson CC, Wiener RS, Wisnivesky J. Research Priorities for Interventions to Address Health Disparities in Lung Nodule Management: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Mar 15;207(6):e31-e46. doi: 10.1164/rccm.202212-2216ST.
- Results publication: PubMed 35040882Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generative AI Based Puncture Surgery Navigation System and Cone beam CT in people with Lung Nodules, 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 4 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: finished, as of the sponsor's last update on 23 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture needles of participants for GPS and CBCT-guided 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 NCT06762613, which also lists 6 linked publications.
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 23 Jul 2025.