3D Printing for Nodule Localization

Lung Cancer Clinical Trial

Official title:

Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056923
• Other study ID #: 3D printing navigation
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2019
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Implementation of lung cancer screening using low-dose computed tomography has increased the rate of detection of small peripheral pulmonary nodules. However, it is hard to localize these nodules by palpation because of their small volume and long distance to the nearest pleural surface. To further clarify the confounding factors, we developed our own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, our procedure was performed in the operating room without CT scan evaluation.

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. In recent years, the three-dimensional (3D) printing technique has been gradually applied to clinical therapy. However, 3D-printed template-guided (3D-G) localization required pre-evaluation by CT scanning. If deviation of more than 2 cm was found on the CT scan, the 3D-G method was regarded as a failure and traditional CT-G hookwire localization was used. To further clarify the confounding factors, the investigators developed their own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, the 3D printing localization procedure was performed in the operating room without CT scan evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 1, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a maximum target lung nodule diameter =20 mm;

• a target nodule consolidation/tumor ratio (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.

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, Solitary
• Solitary Pulmonary Nodule

Intervention

Procedure:
• 3D-printing guided
3D printed navigational template guided
• CT-guided
CT-guided

Drug:
• Indocyanine Green
The results are shown by comparison of different colors.
• Methylene blue
The results are shown by comparison of different colors.

Procedure:
• Preoperative
Preoperative localization.
• Intraoperative
Intraoperative localization.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Wen-zhao ZHONG	Zhuhai Seine Technology Co., Ltd, Zhuhai city, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization distance	The distance of the two stain points from the tumor. The investigators use a sterile, standard ruler to measure the distance. Based on our previous experience with CT-G localization, a deviation of less than 2 cm was considered a successful localization.	Day of surgery