Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

NCT ID: NCT06548451

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-09-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AR-guided group

Application of augmented reality technique for percutaneous lung nodule localization.

Group Type: EXPERIMENTAL

Augmented reality guided localization

Intervention Type: DEVICE

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.

CT-guided group

Computerized tomography (CT) guided percutaneous lung nodule localization.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Augmented reality guided localization

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 80 years inclusive;

2. No distant metastasis in preoperative clinical assessment;

3. The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;

4. Target lung nodule diameter is no more than 2 cm;

5. The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;

6. Non-pleural surface nodules;

7. Preoperative ECOG performance status score of 0/1;

8. Voluntarily participating in this study and signing an informed consent form.

Exclusion Criteria

1. More than two lung nodules need to be removed at the same time.

2. 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.

3. Patients with chronic pain issues or those who have been taking pain medications for an extended period.

4. Patients have uncontrollable mental illness and cannot make subjective assessment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xinghua Cheng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

the people's second hospital Hefei

Hefei, , China

Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, , China

Jining No. 1 People's Hospital.

Jining, , China

Donghai County People's Hospital

Lianyungang, , China

the First Hospital of Hebei Medical University

Shijia Zhuang, , China

Zhangjiagang Hospital of Traditional Chinese Medicine,

Zhangjiagang, , China

Countries

China

Other Identifiers

ShanghaiChestAR_multicentered

Identifier Type: -

Identifier Source: org_study_id