Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules

Lung Cancer Clinical Trial

— MR&3D Local  

Official title:

Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552054
• Other study ID #: 46783912
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2020
• Source: Guangdong Provincial People's Hospital
• Contact: Wen-Zhao Zhong, Ph.D
• Phone: +86-13609777314
• Email: 13609777314[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the viability and accuracy of preoperative mixed reality technique combined with three-dimensional printing navigational template guided localizing pulmonary small nodules.

Description:

Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. Mixed reality (MR) technique aims to enhance the simple self-visual effect and facilitate visualization of the surrounding environment in any situation. The three-dimensional model can be visualized by MR technique through MR glasses. Investigators project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest, and then use this as a guide for percutaneous lung puncture localization. At the same time, investigators design an three-dimensional printing navigational template based on the 3D reconstruction model and place it on the surface of the body to help to guide the localization. This study is designed to evaluates the viability and accuracy of preoperative mixed reality technique combined with 3D printing navigational template guided localizing pulmonary nodules.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 1, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a maximum target lung nodule (one or more) diameter =20 mm

• a target nodule CTR <0·25 or a minimum distance from the outer edge of the nodule to the nearest pleural surface >10 mm if the target nodule CTR was >0·25.

• Plan to perform VATS lung wedge resection

Exclusion Criteria:

• Inability to comply with research protocols or research procedures

• Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (= New York Heart Association [NYHA] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease

• Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture

• Pregnant or lactating women

• Other circumstances that the investigator believes are not suitable for enrollment

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule
• Video-assisted Thoracic Surgery

Intervention

Device:
• Mixed Reality+ 3D printing guided localization
Researchers project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest. Finally, researchers put the three-dimensional printing navigational template on the surface of the body to guide for percutaneous lung puncture localization.
• Computerized Tomography guided localization
CT-guided percutaneous lung puncture staining marker localization.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Wen-zhao ZHONG	Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puncture success rate of localization	The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.	During surgery
Secondary	Time of localization	To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively.	During surgery