Lung CancerNCT06548451
Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial
A study testing Augmented reality guided localization in people with Lung Cancer, run by Shanghai Chest Hospital at 8 sites in China.
Trial summary
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Augmented reality guided localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 8 sitesChina
- Study dates
- 15 Aug 2024to 30 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years inclusive;
- No distant metastasis in preoperative clinical assessment;
- The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
- Target lung nodule diameter is no more than 2 cm;
- The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
- Non-pleural surface nodules;
- Preoperative ECOG performance status score of 0/1;
- Voluntarily participating in this study and signing an informed consent form.
Who cannot join
- More than two lung nodules need to be removed at the same time.
- The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
- Patients with chronic pain issues or those who have been taking pain medications for an extended period.
- Patients have uncontrollable mental illness and cannot make subjective assessment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
the people's second hospital Hefei
Hefei
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin
Jining No. 1 People's Hospital.
Jining
Donghai County People's Hospital
Lianyungang
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030
the First Hospital of Hebei Medical University
Shijia Zhuang
Zhangjiagang Hospital of Traditional Chinese Medicine,
Zhangjiagang
About this study
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.
- Conditions
- Lung Cancer
- Being tested
- Augmented reality guided localization
- Keywords
- augmented reality, localization, sublobectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality guided localizationDevice
In this study, AR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique.
| Study group | Role | What they receive |
|---|---|---|
| AR-guided group | Experimental | Application of augmented reality technique for percutaneous lung nodule localization. Receives: Device: Augmented reality guided localization |
| CT-guided group | No intervention | Computerized tomography (CT) guided percutaneous lung nodule localization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of sublobar resection
The surgeon assesses whether effective lung sublobar resection has been achieved intraoperatively. Effective lung sublobar resection is defined as: (1) Completing planned sublobar resection in one session without the need for supplementary segmental or lobar resections; (2) Having a margin distance from the nodule of over 2 cm or at least 1 times the diameter of the nodule. If effective resection is not achieved, the proportion of supplementary segmental or lobar resections will be recorded.
Measured: 120 minutes
Secondary outcomes (8)
Operation duration
Since the start/end point of CT-guided pulmonary nodule localization may be arbitrary and there may be differences between different researchers, the program duration is derived from the CT scanning parameters and calculated as the length of time between the initial scan and the final scan. The augmented reality (AR) guided positioning time is automatically recorded by the system from the beginning of registration to the completion of positioning.
Measured: 30 minutes
Interval time from localization to surgery
The time from completion of localization to the start of skin incision for surgery is calculated as the interval time from localization to surgery for both groups.
Measured: 60 minutes
Complications related to nodule localization
- CT-guided group: CT-guided localization is performed with the presence of research personnel or assistants to ensure compliance with the study protocol and to collect information on complications on-site. Occurrences of pneumothorax and pulmonary hemorrhage are immediately assessed after localization. Other rare complications such as vasovagal reactions and hemoptysis are also documented. After lung nodule localization, patients are taken to the anesthesia waiting area. During this time, nurses closely monitor the patients for worsening pneumothorax. Any occurrences of hemoptysis or other discomfort are meticulously recorded.
- AR-guided group: Due to the inability to assess pneumothorax and hemoptysis in AR-guided group, the anesthesiologist will be responsible for recording instances of airway bleeding and pneumothorax leading to decreased oxygen levels.
Measured: 60 minutes
Radiation exposure dose
The dose length product (DLP) was used to quantify the total radiation received by patients during the localization of pulmonary nodules. In addition, after the scanning process, the DLP value is directly displayed on the screen of the CT scanner. In order to estimate the relative amount of radiation dose, the effective dose (ED) is also calculated according to the DLP value.
Measured: 30 minutes
Dislodgement rate of the hookwire
The dislodgement of the hookwire is recorded by the operating surgeon or research assistant intraoperatively. Additionally, due to the impact of nodule depth on dislodgement rate, the distance between the lung nodule and the lung puncture point is also recorded.
Measured: 120 minutes
Accuracy of nodule localization
The deviation between the hookwire and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.
Measured: 30 minutes
Post-localization pain assessment
The post-localization pain assessment is conducted by the research assistant blindedly on the first day after surgery when the patient is fully awake. The assessment includes evaluating the patient's pain level during the localization process and at the localization site on the first day after surgery using the Numerical Rating Scale (NRS) for scoring. Additionally, pain assessment is repeated on the second day after surgery and again at 30 days after discharge (±7 days).
Measured: 40 days
Post-localization trauma stress disorder assessment
The post-localization trauma stress disorder assessment is conducted by the research assistant in a blinded manner on the second day after surgery and at 30 days after discharge (±7 days). The Post-traumatic Stress Disorder Checklist - Civilian Version (PCL-C) is used to evaluates the psychological trauma experienced by patients due to the localization procedure.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start15 Aug 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
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 CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinghua Cheng, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548451
- Sponsor's protocol ID
- ShanghaiChestAR_multicentered
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song Z, Wang Z, Yao H, Tian Q, Liu R, Chen L, Sun M, Ma W, Gong X, Sun C, Xi J, Chen Z, Yu L, Wang Y, Kan CS, Pezzella M, Gao C, Liu H, Cheng X. Single-Encounter Augmented Reality-Guided Localization for Resection of Suspected Early-Stage Lung Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 Jul 8. doi: 10.1001/jamasurg.2026.2516. Online ahead of print.
PubMed 42418181
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06548451
- Acronym / sponsor ID
- ShanghaiChestAR_multicentered
- Conditions
- Lung Cancer
- Keywords
- augmented reality, localization, sublobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 12 Aug 2024 (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.
With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR-guided group | Experimental | Device: Augmented reality guided localizationApplication of augmented reality technique for percutaneous lung nodule localization. |
| CT-guided group | No intervention | –Computerized tomography (CT) guided percutaneous lung nodule localization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 80 years inclusive;
- No distant metastasis in preoperative clinical assessment;
- The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
- Target lung nodule diameter is no more than 2 cm;
- The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
Key exclusion criteria (4 listed)
- More than two lung nodules need to be removed at the same time.
- The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
- Patients with chronic pain issues or those who have been taking pain medications for an extended period.
- Patients have uncontrollable mental illness and cannot make subjective assessment.
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 |
|---|---|---|
| Augmented reality guided localizationIn this study, AR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique. | Device | AR-guided group |
Primary outcome
Effectiveness of sublobar resection
Time frame: 120 minutes
The surgeon assesses whether effective lung sublobar resection has been achieved intraoperatively. Effective lung sublobar resection is defined as: (1) Completing planned sublobar resection in one session without the need for supplementary segmental or lobar resections; (2) Having a margin distance from the nodule of over 2 cm or at least 1 times the diameter of the nodule. If effective resection is not achieved, the proportion of supplementary segmental or lobar resections will be recorded.
8 secondary outcomes
Operation duration
Time frame: 30 minutes
Interval time from localization to surgery
Time frame: 60 minutes
Complications related to nodule localization
Time frame: 60 minutes
Radiation exposure dose
Time frame: 30 minutes
Dislodgement rate of the hookwire
Time frame: 120 minutes
Accuracy of nodule localization
Time frame: 30 minutes
Post-localization pain assessment
Time frame: 40 days
Post-localization trauma stress disorder assessment
Time frame: 40 days
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 28 Nov 2025.
- Derived from this study: PubMed 42418181Song Z, Wang Z, Yao H, Tian Q, Liu R, Chen L, Sun M, Ma W, Gong X, Sun C, Xi J, Chen Z, Yu L, Wang Y, Kan CS, Pezzella M, Gao C, Liu H, Cheng X. Single-Encounter Augmented Reality-Guided Localization for Resection of Suspected Early-Stage Lung Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 Jul 8. doi: 10.1001/jamasurg.2026.2516. Online ahead of print.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality guided localization in people with Lung Cancer, run by Shanghai Chest Hospital at 8 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 8 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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?
Effectiveness of sublobar resection (time frame: 120 minutes). 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 NCT06548451, 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 28 Nov 2025.