SPNARPLNCT05162235
Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection
A study testing Augmented Reality-assisted localization of solitary pulmonary nodule in people with SPN and Lung Cancer, run by Shanghai Chest Hospital.
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?
- Any age
- Conditions the study is for
- SPN, Lung Cancer
- What is being tested?
- Augmented Reality-assisted localization of solitary pulmonary nodule
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First diagnosed as IA Stage Lung cancer
- Manifested as Solitary Pulmonary Nodule (SPN) with diameter less than 2cm
- Prepared for pulmonary lobectomy
- The cardiac-pulmonary function and hepatorenal function are eligible for pulmonary surgery
Who cannot join
- patients with previous pulmonary surgical history.
- patients who had chemotherapy or radiological therapy.
Trial locations and contacts
No sites are listed yet.
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.
Read the detailed description
- Overall objective:
- Research and development of puncturing system of preoperative rapid positioning of lung nodules under the guidance of augmented reality images with hook-wire.
- Accurate sublobectomy of early-stage lung cancer assisted by thoracoscopic positioning needle and virtual imaging to relieve the pain caused by localization of pulmonary nodule, reduce the risk of puncturing.
- Innovation points:
- Establish an accurate fitting database of 3D virtual lung model reconstructed from CT scans. Because the patient's posture may be different when in CT scan and under general anesthesia, and also affected by breathing at the same time, it may cause difference between the virtual lung and the real one. In addition, during the operation of the thoracoscopy, lungs are in a collapsed state. Therefore, in order to achieve an accurate fit between virtual and reality lung, it is necessary to generate a virtual lung model that can be automatically adjusted according to body surface markers and lung anatomical markers. This technology has not yet been reported in the field of digital reconstruction of lung.
- Through augmented reality technology, puncturing localization of lung nodule will not necessarily depend on multiple CT scan. Puncture can be performed under general anesthesia pre-operatively, which can relieve the pain of the patient, reduce the cost of puncture and the harm of complications, and reduce the radiation exposure of the patient and the doctor. This technical concept has not been reported.
- Detailed description 20 patients with solitary pulmonary nodule were selected and prepared for VATS sublobectomy. For this clinical study, after fixing the enrolled patients on the operating bed, they were general anesthetized to reduce oral and airway secretions. The patients were intubated, the ventilator was connected, and vital signs were monitored. Markers will be set on their chest three days before surgery and CT scan will be performed for everyone. The digital imaging and communications (DICOM) image data obtained from the scan were stored. After the first CT scan for each patient, a 3D Mask of patient was constructed and cropped using the Crop Mask function and the Erase curve erasing tool in Edit Masks; using the Calculate Part tool to calculate the 3D model of each part; STL format files of the model were exported separately to Autodesk FBX format for the subsequent development and study; Autodesk FBX model and Vuforia Image Target database were imported into Unity to create a suitable AR scene. After compiling the data, the C# solution was generated and deployed into Microsoft HoloLens before starting the AR surgical system. Hook-wire was used for percutaneous puncture according to the AR localization of the SPNs.
- Data collection During the procedure, the angles between the planned and actual puncture paths, the distance between the planned entry point and the punctured point, and the distance between the planned and actual puncture depths were all recorded and calculated. Another CT scan was took before the calculation for each patient to evaluate the puncture result. The three-dimensional position of the puncture needle was reconstructed by JinSe MIDIVI Intelligent Cloud Platform (JinSe Medical Co., Ltd. Shanghai, China). Then the three-dimensional puncture needle was compared with the preset puncture path. The main parameters for comparison are the angle between the two lines, the difference in the spatial position of the vertices of the two lines, and the distance between the actual entry point and the plan one after the puncture needle enters the body surface. Then these parameters are automatically calculated by the software Materialise 3-matic (Materialise Inc., Belgium). The hit rate of hook-wire localization was also statistically significant.
- Conditions
- SPN, Lung Cancer
- Being tested
- Augmented Reality-assisted localization of solitary pulmonary nodule
- Keywords
- SPN, 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-assisted localization of solitary pulmonary noduleDevice
In this study, AR was utilized to assist in the localization of SPNs during sublobectomy lung resection in patient to assess the safety and effectiveness of the technique.
| Study group | Role | What they receive |
|---|---|---|
| AR-localization | Experimental | Not described Receives: Device: Augmented Reality-assisted localization of solitary pulmonary nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurately localization of SPN
The Hook-wire needle hit the 1 cm area around the SPN under the assistance of AR
Measured: 30 minutes
Miss the target
The Hook-wire needle hit out of the 1cm area around the SPN
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPNStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinghua Cheng, Shanghai Chest Hospital
- Investigators
- Xinghua Cheng, Ph.D, Principal investigator, Shanghai Pulmonary Tumor Medical Center, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162235
- Sponsor's protocol ID
- SHC20210913
- Acronym
- ARPL
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection
- ClinicalTrials.gov ID
- NCT05162235
- Acronym / sponsor ID
- ARPL / SHC20210913
- Conditions
- SPN, Lung Cancer
- Keywords
- SPN, Augmented Reality, Localization, sublobectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Dec 2021 (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.
Detailed description
- Overall objective:
- Research and development of puncturing system of preoperative rapid positioning of lung nodules under the guidance of augmented reality images with hook-wire.
- Accurate sublobectomy of early-stage lung cancer assisted by thoracoscopic positioning needle and virtual imaging to relieve the pain caused by localization of pulmonary nodule, reduce the risk of puncturing.
- Innovation points:
- Establish an accurate fitting database of 3D virtual lung model reconstructed from CT scans. Because the patient's posture may be different when in CT scan and under general anesthesia, and also affected by breathing at the same time, it may cause difference between the virtual lung and the real one. In addition, during the operation of the thoracoscopy, lungs are in a collapsed state. Therefore, in order to achieve an accurate fit between virtual and reality lung, it is necessary to generate a virtual lung model that can be automatically adjusted according to body surface markers and lung anatomical markers. This technology has not yet been reported in the field of digital reconstruction of lung.
- Through augmented reality technology, puncturing localization of lung nodule will not necessarily depend on multiple CT scan. Puncture can be performed under general anesthesia pre-operatively, which can relieve the pain of the patient, reduce the cost of puncture and the harm of complications, and reduce the radiation exposure of the patient and the doctor. This technical concept has not been reported.
- Detailed description 20 patients with solitary pulmonary nodule were selected and prepared for VATS sublobectomy. For this clinical study, after fixing the enrolled patients on the operating bed, they were general anesthetized to reduce oral and airway secretions. The patients were intubated, the ventilator was connected, and vital signs were monitored. Markers will be set on their chest three days before surgery and CT scan will be performed for everyone. The digital imaging and communications (DICOM) image data obtained from the scan were stored. After the first CT scan for each patient, a 3D Mask of patient was constructed and cropped using the Crop Mask function and the Erase curve erasing tool in Edit Masks; using the Calculate Part tool to calculate the 3D model of each part; STL format files of the model were exported separately to Autodesk FBX format for the subsequent development and study; Autodesk FBX model and Vuforia Image Target database were imported into Unity to create a suitable AR scene. After compiling the data, the C# solution was generated and deployed into Microsoft HoloLens before starting the AR surgical system. Hook-wire was used for percutaneous puncture according to the AR localization of the SPNs.
- Data collection During the procedure, the angles between the planned and actual puncture paths, the distance between the planned entry point and the punctured point, and the distance between the planned and actual puncture depths were all recorded and calculated. Another CT scan was took before the calculation for each patient to evaluate the puncture result. The three-dimensional position of the puncture needle was reconstructed by JinSe MIDIVI Intelligent Cloud Platform (JinSe Medical Co., Ltd. Shanghai, China). Then the three-dimensional puncture needle was compared with the preset puncture path. The main parameters for comparison are the angle between the two lines, the difference in the spatial position of the vertices of the two lines, and the distance between the actual entry point and the plan one after the puncture needle enters the body surface. Then these parameters are automatically calculated by the software Materialise 3-matic (Materialise Inc., Belgium). The hit rate of hook-wire localization was also statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AR-localization | Experimental | Device: Augmented Reality-assisted localization of solitary pulmonary nodule |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- First diagnosed as IA Stage Lung cancer
- Manifested as Solitary Pulmonary Nodule (SPN) with diameter less than 2cm
- Prepared for pulmonary lobectomy
- The cardiac-pulmonary function and hepatorenal function are eligible for pulmonary surgery
Key exclusion criteria (2 listed)
- patients with previous pulmonary surgical history.
- patients who had chemotherapy or radiological therapy.
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-assisted localization of solitary pulmonary noduleIn this study, AR was utilized to assist in the localization of SPNs during sublobectomy lung resection in patient to assess the safety and effectiveness of the technique. | Device | AR-localization |
Primary outcome
Accurately localization of SPN
Time frame: 30 minutes
The Hook-wire needle hit the 1 cm area around the SPN under the assistance of AR
Miss the target
Time frame: 30 minutes
The Hook-wire needle hit out of the 1cm area around the SPN
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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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.
Xinghua Cheng, Ph.D principal investigator
Shanghai Pulmonary Tumor Medical Center, Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality-assisted localization of solitary pulmonary nodule in people with SPN and Lung Cancer, run by Shanghai Chest Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinghua Cheng, Ph.D (+86 17701681215, chengxinghua_001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurately localization of SPN (time frame: 30 minutes). 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 17 Dec 2021.