3D Printing for Nodule Localization

Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Pulmonary Nodule, Solitary
• Intervention / Treatment: Procedure: 3D-printing guided; Drug: Methylene blue; Procedure: Intraoperative; Procedure: CT-guided; Drug: Indocyanine Green; Procedure: Preoperative

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D-printed template-guided(3D-G); Intraoperative 3D-G methylene blue dye marking in the operating room	Procedure: 3D-printing guided; 3D printed navigational template guided; Drug: Methylene blue; The results are shown by comparison of different colors.; Procedure: Intraoperative; Intraoperative localization.
ACTIVE_COMPARATOR: CT-guided(CT-G); Preoperative localization is performed by CT-G indocyanine green marking in the radiology department	Procedure: CT-guided; CT-guided; Drug: Indocyanine Green; The results are shown by comparison of different colors.; Procedure: Preoperative; Preoperative localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wen-zhao ZHONG
• Collaborators: Zhuhai Seine Technology Co., Ltd, Zhuhai city, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): June 7, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Computed Tomography; Lung Neoplasms; Three-Dimensional Printing; Pulmonary Nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: 3D printing navigation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No