Using augmented reality to locate lung nodules before surgery

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

This study is testing if using augmented reality can help doctors find lung nodules more accurately before surgery, compared to the usual method, to improve outcomes for patients with lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 8 sites (Shanghai, Shanghai and 7 other locations)
• Trial ID: NCT06548451 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of augmented reality (AR) technology to assist in the localization of solitary pulmonary nodules prior to surgical procedures, specifically sublobar resections for lung cancer. The trial aims to compare the effectiveness of AR-guided localization against the traditional CT-guided hook-wire positioning method, which can be costly and traumatic for patients. By integrating AR into the surgical process, the study seeks to enhance the precision of nodule localization, potentially improving surgical outcomes and efficiency.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with solitary pulmonary nodules that are less than 2 cm in diameter and require localization for sublobar resection.

Not a fit: Patients with multiple lung nodules or those whose nodules are located in the scapular region may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate and less traumatic surgical procedures for patients with lung cancer.

How similar studies have performed: While the use of augmented reality in surgical settings is emerging, this specific application for lung nodule localization is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Shanghai, Shanghai and 7 other locations

• Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)
• Zhongshan Hospital — Shanghai, Shanghai, China (Recruiting)
• the people's second hospital Hefei — Hefei, China (Recruiting)
• Jiangyin Hospital of Traditional Chinese Medicine — Jiangyin, China (Recruiting)
• Jining No. 1 People's Hospital. — Jining, China (Recruiting)
• Donghai County People's Hospital — Lianyungang, China (Recruiting)
• the First Hospital of Hebei Medical University — Shijia Zhuang, China (Recruiting)
• Zhangjiagang Hospital of Traditional Chinese Medicine, — Zhangjiagang, China (Recruiting)

Study contacts

• Study coordinator: Xinghua Cheng, MD

Conditions Lung Cancer; augmented reality; localization; sublobectomy