Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection (ARPL)
Primary Purpose
SPN, Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Augmented Reality-assisted localization of solitary pulmonary nodule
Sponsored by
About this trial
This is an interventional diagnostic trial for SPN focused on measuring SPN, Augmented Reality, Localization, sublobectomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients with previous pulmonary surgical history.
- patients who had chemotherapy or radiological therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AR-localization
Arm Description
Outcomes
Primary Outcome Measures
Accurately localization of SPN
The Hook-wire needle hit the 1 cm area around the SPN under the assistance of AR
Miss the target
The Hook-wire needle hit out of the 1cm area around the SPN
Secondary Outcome Measures
Full Information
NCT ID
NCT05162235
First Posted
December 5, 2021
Last Updated
December 16, 2021
Sponsor
Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05162235
Brief Title
Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection
Acronym
ARPL
Official Title
Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SPN, Lung Cancer
Keywords
SPN, Augmented Reality, Localization, sublobectomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AR-localization
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Augmented Reality-assisted localization of solitary pulmonary nodule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accurately localization of SPN
Description
The Hook-wire needle hit the 1 cm area around the SPN under the assistance of AR
Time Frame
30 minutes
Title
Miss the target
Description
The Hook-wire needle hit out of the 1cm area around the SPN
Time Frame
30 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
patients with previous pulmonary surgical history.
patients who had chemotherapy or radiological therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Cheng, Ph.D
Phone
+86 17701681215
Email
chengxinghua_001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinghua Cheng, Ph.D
Organizational Affiliation
Shanghai Pulmonary Tumor Medical Center, Shanghai Chest Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection
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