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

Last updated: November 23, 2025
Sponsor: Shanghai Chest Hospital
Overall Status: Completed

Phase

N/A

Condition

Non-small Cell Lung Cancer

Cancer

Lung Cancer

Treatment

Augmented reality guided localization

Clinical Study ID

NCT06548451
ShanghaiChestAR_multicentered
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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 localizationin 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 arteryor 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

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 localizationis obstructed by the scapula, percutaneous localization of pulmonary nodules is notsuitable for such patients.

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

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

Study Design

Total Participants: 270
Treatment Group(s): 1
Primary Treatment: Augmented reality guided localization
Phase:
Study Start date:
August 15, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Zhongshan Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Shanghai Chest Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200030
    China

    Site Not Available

  • Zhongshan Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200030
    China

    Site Not Available

  • the people's second hospital Hefei

    Hefei,
    China

    Site Not Available

  • the people's second hospital Hefei

    Hefei 1808722,
    China

    Site Not Available

  • Jiangyin Hospital of Traditional Chinese Medicine

    Jiangyin,
    China

    Site Not Available

  • Jiangyin Hospital of Traditional Chinese Medicine

    Jiangyin 1815251,
    China

    Site Not Available

  • Jining No. 1 People's Hospital.

    Jining,
    China

    Site Not Available

  • ining No. 1 People's Hospital.

    Jining,
    China

    Active - Recruiting

  • Jining No. 1 People's Hospital.

    Jining 1805518,
    China

    Site Not Available

  • Donghai County People's Hospital

    Lianyungang,
    China

    Site Not Available

  • Donghai County People's Hospital

    Lianyungang 10859300,
    China

    Site Not Available

  • the First Hospital of Hebei Medical University

    Shijia Zhuang,
    China

    Site Not Available

  • the First Hospital of Hebei Medical University

    Shijia Zhuang 7047979,
    China

    Site Not Available

  • Zhangjiagang Hospital of Traditional Chinese Medicine,

    Zhangjiagang,
    China

    Site Not Available

  • Zhangjiagang Hospital of Traditional Chinese Medicine,

    Zhangjiagang 1787331,
    China

    Site Not Available

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