3D Printing for Nodule Localization

NCT04056923 | Completed

• 1 other identifier: 3D printing navigation
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Nodule, Solitary; Lung Cancer

Keywords

Pulmonary Nodules; Lung Neoplasms; Computed Tomography; Three-Dimensional Printing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

3D-printed template-guided(3D-G)

EXPERIMENTAL

Intraoperative 3D-G methylene blue dye marking in the operating room

Procedure: 3D-printing guided; Drug: Methylene blue; Procedure: Intraoperative

CT-guided(CT-G)

ACTIVE COMPARATOR

Preoperative localization is performed by CT-G indocyanine green marking in the radiology department

Procedure: CT-guided; Drug: Indocyanine Green; Procedure: Preoperative

Interventions

3D-printing guided PROCEDURE

3D printed navigational template guided

3D-printed template-guided(3D-G)

CT-guided PROCEDURE

CT-guided

CT-guided(CT-G)

Indocyanine Green DRUG

The results are shown by comparison of different colors.

CT-guided(CT-G)

Methylene blue DRUG

The results are shown by comparison of different colors.

3D-printed template-guided(3D-G)

Preoperative PROCEDURE

Preoperative localization.

CT-guided(CT-G)

Intraoperative PROCEDURE

Intraoperative localization.

3D-printed template-guided(3D-G)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wen-zhao ZHONG: lead
• Zhuhai Seine Technology Co., Ltd, Zhuhai city, China: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms; Multiple Pulmonary Nodules

Interventions

Indocyanine Green; Methylene Blue

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., Chief physician

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: January 1, 2018
• Primary Completion: June 7, 2018
• Study Completion: July 1, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)