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3D Printing for Nodule Localization

Primary Purpose

Pulmonary Nodule, Solitary, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D-printing guided
CT-guided
Indocyanine Green
Methylene blue
Preoperative
Intraoperative
Sponsored by
Wen-zhao ZHONG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Nodule, Solitary focused on measuring Pulmonary Nodules, Lung Neoplasms, Computed Tomography, Three-Dimensional Printing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

CT-guided(CT-G)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2019
Last Updated
August 13, 2019
Sponsor
Wen-zhao ZHONG
Collaborators
Zhuhai Seine Technology Co., Ltd, Zhuhai city, China
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1. Study Identification

Unique Protocol Identification Number
NCT04056923
Brief Title
3D Printing for Nodule Localization
Official Title
Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen-zhao ZHONG
Collaborators
Zhuhai Seine Technology Co., Ltd, Zhuhai city, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule, Solitary, Lung Cancer
Keywords
Pulmonary Nodules, Lung Neoplasms, Computed Tomography, Three-Dimensional Printing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D-printed template-guided(3D-G)
Arm Type
Experimental
Arm Description
Intraoperative 3D-G methylene blue dye marking in the operating room
Arm Title
CT-guided(CT-G)
Arm Type
Active Comparator
Arm Description
Preoperative localization is performed by CT-G indocyanine green marking in the radiology department
Intervention Type
Procedure
Intervention Name(s)
3D-printing guided
Intervention Description
3D printed navigational template guided
Intervention Type
Procedure
Intervention Name(s)
CT-guided
Intervention Description
CT-guided
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
The results are shown by comparison of different colors.
Intervention Type
Drug
Intervention Name(s)
Methylene blue
Intervention Description
The results are shown by comparison of different colors.
Intervention Type
Procedure
Intervention Name(s)
Preoperative
Intervention Description
Preoperative localization.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative
Intervention Description
Intraoperative localization.
Primary Outcome Measure Information:
Title
Localization distance
Description
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.
Time Frame
Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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3D Printing for Nodule Localization

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