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

NCT05715996 | Unknown

• 1 other identifier: ShanghaiChestMR
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

mixed reality; Localization; sublobectomy

Outcome Measures

Primary Outcomes (1)

• Accuracy of nodule localization

  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 Outcomes (4)

• Operation duration

  30 minutes

• Incidence of complications

  7 days

• Radiation exposure dose

  30 minutes

• Postoperative puncture pain assessment

  7 days

Study Arms (2)

mixed reality guided localization group

EXPERIMENTAL

Application of mixed reality technique for percutaneous lung nodule localization.

Device: mixed reality guided localization

Computerized tomography (CT) guided localization group

NO INTERVENTION

Computerized tomography (CT) guided percutaneous lung nodule localization.

Interventions

mixed reality guided localization DEVICE

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.

mixed reality guided localization 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:

• Male or female ≥ 18years of age;
• There was no distant metastasis in preoperative clinical evaluation;
• The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
• Target lung nodule diameter ≤ 2cm
• The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
• preoperative ECOG physical state score 0/1;
• Volunteer to participate in the study and sign the 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.
• The patient has uncontrollable mental illness and cannot make subjective assessment.
• 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;
• 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;
• At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Zuodong Song

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xinghua Cheng, MD

CONTACT

+8617701681215; chengxinghua_001@163.com

Xinghua Cheng

CONTACT

+8617701681215; chengxinghua_001@163.com

Study Design

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

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: May 23, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

CN (1)