Status unknownNCT05162235ARPLUpdated Dec 17, 2021

Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection

An interventional study of Augmented Reality-assisted localization of solitary pulmonary nodule in SPN and Lung Cancer, sponsored by Shanghai Chest Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Sex: All

Study 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.

Read the detailed description

Overall objective:
1. Research and development of puncturing system of preoperative rapid positioning of lung nodules under the guidance of augmented reality images with hook-wire.
2. 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:
1. 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.
2. 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 studied

SPN
Lung Cancer

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Keywords

SPN
Augmented Reality
Localization
sublobectomy

In context

Multiple Pulmonary Nodules

188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.

This study's planned enrollment of 20 is below the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

patients with previous pulmonary surgical history.
patients who had chemotherapy or radiological therapy.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
AR-localization
Device: Augmented Reality-assisted localization of solitary pulmonary nodule

Interventions

DeviceAugmented Reality-assisted localization of solitary pulmonary nodule
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.

What researchers measure

Primary outcomes

Accurately localization of SPN
The Hook-wire needle hit the 1 cm area around the SPN under the assistance of AR
Time frame: 30 minutes
Miss the target
The Hook-wire needle hit out of the 1cm area around the SPN
Time frame: 30 minutes

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05162235
Lead sponsor: Shanghai Chest Hospital
Responsible party: Xinghua Cheng (Prof., Shanghai Chest Hospital) — Principal investigator
First posted: Dec 17, 2021
Start date: Jan 1, 2022 (estimated)
Primary completion: Dec 31, 2023 (estimated)
Completion: Dec 31, 2023 (estimated)
Last update: Dec 17, 2021

Study contacts

Xinghua Cheng, Ph.D

Contact

chengxinghua_001@163.com

+86 17701681215

Xinghua Cheng, Ph.D

principal investigator · Shanghai Pulmonary Tumor Medical Center, Shanghai Chest Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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