Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial (MR)

November 20, 2023 updated by: Xinghua Cheng, Shanghai Chest Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female ≥ 18years of age;
  2. There was no distant metastasis in preoperative clinical evaluation;
  3. The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
  4. Target lung nodule diameter ≤ 2cm
  5. The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
  6. preoperative ECOG physical state score 0/1;
  7. Volunteer to participate in the study and sign the 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. The patient has uncontrollable mental illness and cannot make subjective assessment.
  4. After being selected, severe complications (unable to tolerate surgery or anesthesia) occurred before operation are not suitable or the treatment plan of the study cannot be implemented as planned;
  5. After being selected, the patient's condition changes and needs to be changed from elective surgery to emergency surgery after being confirmed by the competent doctor;
  6. At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mixed reality guided localization group
Application of mixed reality technique for percutaneous lung nodule localization.
Device: mixed reality guided localization
In this study, MR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique.
No Intervention: Computerized tomography (CT) guided localization group
Computerized tomography (CT) guided percutaneous lung nodule localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of nodule localization
Time Frame: 30 minutes
The deviation between the local quantizer and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation duration
Time Frame: 30 minutes
Since the start/end point of CT-guided pulmonary nodule localization may be arbitrary and there may be differences between different researchers, the program duration is derived from the CT scanning parameters and calculated as the length of time between the initial scan and the final scan. The hybrid reality guided positioning time is automatically recorded by the system from the beginning of registration to the completion of positioning
30 minutes
Incidence of complications
Time Frame: 7 days
Including pneumothorax, hemoptysis, circulation changes caused by bleeding, pleural reaction, etc
7 days
Radiation exposure dose
Time Frame: 30 minutes
The dose length product (DLP) was used to quantify the total radiation received by patients during the localization of pulmonary nodules. In addition, after the scanning process, the DLP value is directly displayed on the screen of the CT scanner. In order to estimate the relative amount of radiation dose, the effective dose (ED) is also calculated according to the DLP value
30 minutes
Postoperative puncture pain assessment
Time Frame: 7 days
On the first day after the operation, when the patient was fully awake, the pain degree of the patient during the positioning process was evaluated by using the NRS (digital scoring method) and the Digital Assessment Scale of Pain Degree. The degree of pain is expressed in 0-10 numbers, 0 means no pain, and 10 means the most severe pain. It is left to the patient to choose a number that best represents the degree of pain, and the medical staff will select the corresponding number according to the patient's description of pain. According to the corresponding number of pain, the pain degree is divided into mild pain (1-3), moderate pain (4-6), and severe pain (7-10)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ShanghaiChestMR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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