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

NCT06548451 | Completed

• 1 other identifier: ShanghaiChestAR_multicentered
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 8

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

Keywords

augmented reality; localization; sublobectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  120 minutes

Secondary Outcomes (8)

• Operation duration

  30 minutes

• Interval time from localization to surgery

  60 minutes

• Complications related to nodule localization

  60 minutes

• Radiation exposure dose

  30 minutes

• Dislodgement rate of the hookwire

  120 minutes

Study Arms (2)

AR-guided group

EXPERIMENTAL

Application of augmented reality technique for percutaneous lung nodule localization.

Device: Augmented reality guided localization

CT-guided group

NO INTERVENTION

Computerized tomography (CT) guided percutaneous lung nodule localization.

Interventions

Augmented reality guided localization 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.

AR-guided group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (8)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

the people's second hospital Hefei

Hefei, China

Location

Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, China

Location

Jining No. 1 People's Hospital.

Jining, China

Location

Donghai County People's Hospital

Lianyungang, China

Location

the First Hospital of Hebei Medical University

Shijia Zhuang, China

Location

Zhangjiagang Hospital of Traditional Chinese Medicine,

Zhangjiagang, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: August 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2024-10

Locations

CN (8)