Peripheral Pulmonary Lesions (PPLs)NCT07149597
Clinical Validation Study on the Imaging Efficacy of Mobile 4D CBCT Technology for Peripheral Pulmonary Lesions
An observational study of Peripheral Pulmonary Lesions (PPLs), run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions and to validate its intraoperative dynamic three-dimensional CT imaging capability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions (PPLs)
- What is being tested?
- Mobile CBCT Three-Dimensional Scanning
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent mobile CBCT scanning.
Who may be able to join
- Age >18 years old.
- Patients whose chest CT scans indicate the presence of peripheral pulmonary lesions and require further diagnosis via transbronchial lung biopsy (TBLB).
- Lesion size: 8 mm < longest diameter of lesion ≤ 50 mm.
- Understands the study and has provided signed informed consent.
Who cannot join
- Contraindications to bronchoscopy are present.
- Severe cardiopulmonary dysfunction or other conditions that may increase surgical risk.
- The investigator considers that the patient has other conditions which make them unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai
Jiayuan Sun, +1511 +86-021-22200000, jysun1976@163.com
About this study
The purpose of this study is to evaluate the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions and to validate its intraoperative dynamic three-dimensional CT imaging capability.
Read the detailed description
This is a single-arm, single-center, prospective study in which approximately 50 patients with peripheral pulmonary lesions will undergo mobile cone-beam computed tomography (CBCT) scanning. In the field of respiratory intervention, mobile CBCT enables real-time intraoperative three-dimensional CT imaging of lesions, providing a more intuitive visualization of the positional relationship between biopsy tools and the target area, offering significant value in bronchoscopic examinations. In this study, CBCT images will be acquired from participants and reconstructed into three-dimensional models. Subsequent analysis will be conducted to evaluate the performance of mobile 4D CBCT three-dimensional reconstruction technology.
- Conditions
- Peripheral Pulmonary Lesions (PPLs)
- Being tested
- Mobile CBCT Three-Dimensional Scanning
- Keywords
- Mobile Cone-Beam Computed Tomography, Artificial Intelligence, Peripheral Pulmonary Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile CBCT Three-Dimensional ScanningRadiation
Mobile CBCT Three-Dimensional Scanning
| Study group | Role | What they receive |
|---|---|---|
| Mobile CBCT Group | This study aims to explore the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions, and to validate its intraoperative three-dimensional CT imaging capability. Preoperative fluoroscopic localization will be performed, followed by two rounds of three-dimensional scanning using a mobile C-arm system to acquire volumetric CT images of the patients. The obtained images will be exported and processed postoperatively, and analyzed from both quantitative and qualitative perspectives. Receives: Radiation: Mobile CBCT Three-Dimensional Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMSE（Root Mean Squared Error）
RMSE (Root Mean Square Error): A commonly used metric for measuring the difference between predicted values and actual values. It is applicable in regression problems and image quality assessment. A smaller RMSE value indicates more accurate predictions, with 0 representing perfect accuracy, while a larger value indicates greater error.
Measured: 1 year
SSIM (Structural Similarity )
SSIM (Structural Similarity ): A metric used to measure the similarity between two images, comparing them across three dimensions: luminance, contrast, and structure. The SSIM value ranges from [-1, 1], where 1 indicates that the two images are identical, and 0 or negative values indicate complete dissimilarity.
Measured: 1 year
Secondary outcomes (2)
Image Quality
Three experienced experts scored the three-dimensional CT reconstruction images based on image quality using the following criteria:4 points: Exceptionally clear images;3 points: Generally clear images with a few blurred slices;2 points: Basically clear images but with several blurred slices;1 point: Unclear images.
Measured: 1 year
Slice Continuity
Three experienced experts scored the three-dimensional CT reconstruction images based on slice continuity using the following criteria:4 points: All slices exhibit continuous anatomical structures;3 points: Overall continuous with minor discontinuities in a few slices;2 points: Generally continuous but with noticeable discontinuities in multiple slices;1 point: Predominantly discontinuous across most slices.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Pulmonary Lesions (PPLs)Studies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149597
- Sponsor's protocol ID
- IS25179
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study on the Imaging Efficacy of Mobile 4D CBCT Technology for Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT07149597
- Acronym / sponsor ID
- IS25179
- Conditions
- Peripheral Pulmonary Lesions (PPLs)
- Keywords
- Mobile Cone-Beam Computed Tomography, Artificial Intelligence, Peripheral Pulmonary Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Sep 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 purpose of this study is to evaluate the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions and to validate its intraoperative dynamic three-dimensional CT imaging capability.
Detailed description
This is a single-arm, single-center, prospective study in which approximately 50 patients with peripheral pulmonary lesions will undergo mobile cone-beam computed tomography (CBCT) scanning. In the field of respiratory intervention, mobile CBCT enables real-time intraoperative three-dimensional CT imaging of lesions, providing a more intuitive visualization of the positional relationship between biopsy tools and the target area, offering significant value in bronchoscopic examinations. In this study, CBCT images will be acquired from participants and reconstructed into three-dimensional models. Subsequent analysis will be conducted to evaluate the performance of mobile 4D CBCT three-dimensional reconstruction technology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile CBCT Group | – | Radiation: Mobile CBCT Three-Dimensional ScanningThis study aims to explore the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions, and to validate its intraoperative three-dimensional CT imaging capability. Preoperative fluoroscopic localization will be performed, followed by two rounds of three-dimensional scanning using a mobile C-arm system to acquire volumetric CT images of the patients. The obtained images will be exported and processed postoperatively, and analyzed from both quantitative and qualitative perspectives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent mobile CBCT scanning.
Key inclusion criteria (4 listed)
- Age >18 years old.
- Patients whose chest CT scans indicate the presence of peripheral pulmonary lesions and require further diagnosis via transbronchial lung biopsy (TBLB).
- Lesion size: 8 mm < longest diameter of lesion ≤ 50 mm.
- Understands the study and has provided signed informed consent.
Key exclusion criteria (3 listed)
- Contraindications to bronchoscopy are present.
- Severe cardiopulmonary dysfunction or other conditions that may increase surgical risk.
- The investigator considers that the patient has other conditions which make them unsuitable for participation in this study.
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 |
|---|---|---|
| Mobile CBCT Three-Dimensional ScanningMobile CBCT Three-Dimensional Scanning | Radiation | Mobile CBCT Group |
Primary outcome
RMSE（Root Mean Squared Error）
Time frame: 1 year
RMSE (Root Mean Square Error): A commonly used metric for measuring the difference between predicted values and actual values. It is applicable in regression problems and image quality assessment. A smaller RMSE value indicates more accurate predictions, with 0 representing perfect accuracy, while a larger value indicates greater error.
SSIM (Structural Similarity )
Time frame: 1 year
SSIM (Structural Similarity ): A metric used to measure the similarity between two images, comparing them across three dimensions: luminance, contrast, and structure. The SSIM value ranges from [-1, 1], where 1 indicates that the two images are identical, and 0 or negative values indicate complete dissimilarity.
2 secondary outcomes
Image Quality
Time frame: 1 year
Slice Continuity
Time frame: 1 year
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 8 Sep 2025.
- 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.
Jiayuan Sun study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Pulmonary Lesions (PPLs), run by Shanghai Chest Hospital at 1 site 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 4 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Jiayuan Sun (+1511 +86-021-22200000, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMSE（Root Mean Squared Error） (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.