Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial
Phase: NA
Conditions: Lung Neoplasm, Thoracic Surgery, Video-Assisted
Sponsor: Chang Chen

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
 
 
Title 
Application of 3D printing technique in small pulmonary nodule 
localization: A Prospective, Randomized, Controlled, Non-
inferiority Trial  
Grant 
Nature Science Foundation of China (81570014) and Shanghai 
Hospital Develop Center(16CR3018A)  
Principal Investigator 
 Chang chen 
Sponsor 
Shanghai Pulmonary Hospital, Tongji university, Shanghai, China 
 
Version Number:  1.0 
01-10-2016 
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with Declaration of 
Helsinki, International Conference on Harmonization guidelines for Good 
Clinical Practice (ICH E6) and Medical Equipment Specification for the 
Quality 
Control 
of 
Clinical 
Trial 
(State 
Food 
and 
Drug 
Administration/National 
Health 
and 
Family 
Planning 
Commission/Number twenty-fifth). All personnel involved in the conduct 
of this study have completed human subject protection training.  
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and provides 
the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements. 
Principal Investigator: 
Signed:  
Date:  
 
Name: Chang Chen 
 
Title: MD., Ph.D. 
 
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
Table of Contents 
STATEMENT OF COMPLIANCE………………………………………………………..2 
SIGNATURE PAGE………………………………………………………………………...3 
TABLE OF CONTENTS………………………………………………………………........4 
PROTOCOL SUMMARY…………………………………………………………….5 
LIST OF ABBREVIATIONS…………………………………………………………........6 
INTRUDUCTION……………………………………………………………………..8 
OBJECTIVES………………………………………………………………………..11 
STUDY DESIGN………………………………………………………………….....13 
STUDY ENROLLMENT AND WITHDRAW……………………………………...16 
STUDY INTERVENTION…………………………………………………………..19 
OUTCOME EVALUATION………………………………………………………...20 
ETHICS AND PROTECTION OF HUMAN SUBJECTS……………..23 
DATA STORAGE POLICY………………………………………………………....26 
 
 
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
PROTOCOL SUMMARY 
Title: Application of 3D printing technique in small pulmonary nodule 
localization: A Prospective, Randomized, Controlled, Non-inferiority 
Trial. 
Objective: To evaluate the accuracy and safety of template-guided lung 
nodule localization compared to standard computed tomography (CT)-
guided localization. 
Participants: Surgical candidates with solitary pulmonary nodule <2 cm 
will be approached prior to scheduled lung resection. The necessity of 
preoperative nodule localization would also be evaluated by the patient’s 
operating surgeon in charge. After acquiring patients’ consent to 
participate into the study, enrolled patients will be randomized into the CT- 
or template-guided group using a previously generated random table. 
According to priori study, each group would have a sample size of 100 
participants.  
Number of site: This is a single-center trial and all participants would be 
recruited in Shanghai Pulmonary Hospital. 
Description of Intervention: The three-dimensional printed, navigational 
template was created to guide percutaneous lung nodule localization. Its 
utility has been tested in previous feasibility trial.  
Estimated Study Duration: From 01-10-2016 to 01-07-2019. 
Estimated Time to Complete Enrollment: From 01-10-2016 to 01-06-
2019. 
 
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
Schematic of Study Design 
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
LIST OF ABBREVIATIONS 
 
3D  
three-dimensional  
CT 
computed tomography  
GGO 
ground glass nodule 
VATS 
video assisted thoracoscopic surgery 
 DLP                dose-length product 
 ED                   effective dosage  

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
1 INTRODUCTION: BACKGROUND INFORMATION AND 
SCIENTIFIC RATIONALE  
1.1 
Background information 
With the widespread utilization of high resolution low-dosage CT 
scan in lung cancer screening, small lung nodules less than 1 cm in 
diameter are detected more often than ever. Biopsy resection by video-
assisted thoracoscopic surgery(VATS) is an ideal option to diagnose and, 
at the same time, offer a curative intervention. In the dairy practice of 
thoracic surgery, small lung nodule resection by VATS has accounts for a 
large proportion.  
Small-sized nodules, however, especially ground-glass opacity 
(GGO)-dominant nodules located deep in the lung parenchyma, are 
difficult to recognize during VATS. It was reported that failure of nodule 
localization is the most common reason leading to conversion to 
thoracotomy. In order to deal with this problem, there have developed 
many modalities to preoperatively localize the target lung nodule to 
facilitate nodule resection by VATS. Among those, percutaneous 
transthoracic lung nodule localization is the most frequently used approach 
because of its simplicity and independence of special equipment. Usually, 
the patients is taken into the CT room to receive lung nodule localization 
under CT guidance before the scheduled surgery. Despite its assistance in 
successful nodule resection by VATS, CT-guided percutaneous 
localization is sometimes arduous and requires many times of localizer 
redirection. Especially when the interventional radiologist is less 
experienced, it often takes many times of CT scans to accurately localize 
the target nodule.  
With the purpose of facilitating nodule localization procedure and 
reduce radiation exposure, a navigational template was created using three-

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
dimensional (3D) printing technology and its utilization in clinical 
application has been preliminarily tested in previous study.    
1.2 
Rationale 
The navigational template is created based on patient’s CT images. 
Firstly, the CT data is downloaded from Picture Archiving and 
Communication Systems (PACS), then imported into the computer-aided 
design (CAD) software to reconstruct patient’s thoracic digital model. 
According to this digital model, the navigational template was designed to 
mark the puncture site and angle of the localizer prior to nodule 
localization. In order to achieve accurate template placement on patient’s 
thorax, several anatomical landmarks were marked on the template to 
check for template alignment. 
 With the assistance of navigational template, the practitioner does 
not need to manually calculate the inserting site and angle according to the 
two-dimensional image, but insert the localizer according to the guidance 
of template. 
1.3 
Potential Risks and Benefits 
1.3.1 Potential Risks 
The mechanism of template-guided lung nodule localization is the 
same as conventional CT-guided localization. Therefore, complications 
related to percutaneous lung nodule localization such as pain, pulmonary 
hemorrhage, pneumothorax, hemoptysis and so on, likely occur. Most of 
these complication is non-significant and do not need special intervention.  

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
For patient assigned to receive templated-guided nodule localization, 
the most worrying concern is the accuracy of lung nodule localization. 
Firstly, the previous feasibility trial has confirmed the precision of the 
navigational template, with 10.0 mm of the median localizer deviation and 
no occurrence of severe complications in template-guided localization. 
Secondly, for the sake of safety of participants in this trial，patients would 
receive CT scan to confirm the accuracy of the template-guided lung 
nodule localization after template placement but before localizer insertion. 
Regarding to the concern of infection, the entire template was 
sterilized by UV irradiation for 30 minutes and the area adjacent to 
puncture point was sterilized using iodine. And the metal introducer sheath, 
through which the localizer was introduced, was sterilized using autoclave 
sterilizer. And infection of the puncture site was not found in our 
previous study. Additionally, as the template is made of nylon (PA3200), 
patients with a history of nylon allergy should not receive template-guided 
localization. 
1.3.2 Potential Benefits 
Based on our priori study, the application of 3D-printed template in 
lung nodule localization might facilitate the process of lung nodule 
localization. In template-guided lung nodule localization, radiologist do 
not need to measure the puncture site/angle/length from the two-
dimensional CT images. Instead, the template pre-specified the insertion 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
site and angle of the localizer. In this way, the practitioner may not need to 
take repeated attempts to redirecting the localizer, which leads to increased 
radiation exposure and high complication rate. 
Therefore, 
patients 
receiving 
template-guided 
lung 
nodule 
localization would suffer less radiation exposure and lower complication 
rate. For the viewpoint of radiologist, the application of template 
significantly alleviates the challenge on practitioner and simplify the 
procedure of lung nodule localization. Lastly, the conventional CT-guided 
localization method requires the patients to stay still in one position during 
the whole procedure. It might be difficult for some patients, especially with 
obvious cough symptoms.  However, in template-guided localization, the 
requirement about patient’s position was not so strict. Patients might be 
more easily to cooperate in the template-guided lung nodule localization.  
2   OBJECTIVES 
2.1   Study Objectives 
To evaluate the safety and accuracy of navigational template-guided 
method in percutaneous lung nodule localization. 
2.2   Study Outcome  
2.2.1   Primary outcome 
The primary outcome of this study is the precision of the lung nodule 
localization, which was specified by the localizer deviation. As the center 
of the nodule is the designed target, localizer deviation is measured 
between the center of nodule and the localizer. Regarding to measurement 
of the localizer deviation, because the localizer and the target nodule might 
be not on the same section of the CT scan, it is impossible to accurately 
measure the deviation from two-dimensional images.   

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
Therefor we reconstruct the CT images upon nodule localization into 
three-dimensional virtual model, and precisely measure the localizer 
deviation in three dimensions.  
2.2.2   Secondary outcome 
The secondary outcome includes procedural length, radiation 
exposure dosage and related complication rate. 
In order to facilitate the process of data collection, the procedural 
length of nodule localization was inferred from CT scanning parameter. 
The time length of nodule localization is calculated from patients receiving 
the initial CT scan to patients receiving the last CT scan for complication 
evaluation.  And, the radiation exposure dosage (dose-length-product) is 
directly collected from monitor screen after the last CT scanning. The 
complication related to percutaneous lung nodule localization mainly 
includes pneumothorax, pulmonary hemorrhage and hemoptysis during the 
time of waiting for surgery. The occurrence of pneumothorax and 
pulmonary hemorrhage is evaluated by CT scanning immediately after 
localizer release. 
Additionally, localizer dislodgement rate and the margin distance 
reported on frozen analysis are also compared between patients undergoing 
CT-guided nodule localization and patients receiving template-guided 
nodule localization. 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
3 STUDY DESIGN 
The study is designed to be a prospective, randomized, non-
inferiority clinical trial comparing template-guided to CT-guided 
peripheral small lung nodule localization. The feasibility of template-
guided lung nodule localization has already been confirmed in our previous 
study. The study is a phase II clinical trial and further examines the safety 
and efficacy of template-guided lung nodule localization.  
3.1 
Study population and groups 
 
The randomized, controlled trial was approved by the institutional 
review board of Shanghai Pulmonary Hospital. Surgical candidates with 
solitary pulmonary nodule less than 2cm were prospectively recruited prior 
to scheduled lung resection. The necessity of preoperative nodule 
localization was also evaluated by patient’s operating surgeon in charge. 
After acquiring patients’ consent to participate into the study, patients were 
randomized into CT-guided group and template-guided group respectively. 
3.2 
Sample Size Calculation 
 
The study was designed to confirm the non-inferiority of template-
guided lung nodule localization compared to CT-guided lung nodule 
localization in terms of localization accuracy. And the accuracy of lung 
nodule localization was quantified by the localizer deviation between the 
localization and the center of the target nodule. 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
 The expected difference of localizer deviation between CT- and 
template-guided group was 3.5mm according to priori study. Deviation of 
5mm is set as non-interiority margin. We needed to randomize 140 patients 
(70 each group) to give 90% power with one-sided alpha of 0.05. To allow 
for some dropouts, inclusion of 100 patients per group is planned. 
3.3 
Interim Analysis 
An interim-analysis is performed on the primary and secondary 
outcomes when 40% of patients have been randomized. The interim-
analysis is performed by an independent statistician, blinded for the 
treatment allocation. The data monitoring committee will have unblinded 
access to all data and will discuss the results of the interim-analysis in a 
joint meeting, and report to the ethics committee. Based on the results of 
interim-analysis, principal investigator decides whether the trial continues 
or not. The trial will be ended if the localizer deviation is significantly 
larger in template-guided lung nodule localization than CT-guided 
localization, and no benefit is obtained for patients undergoing template-
guided lung nodule localization. Otherwise, the trial will be continued. 
3.4 
Time Schedule 
The trail is planned to start in October 2016 and complete before July 
2019, with about 10 patients enrolled per month. Patients will be followed up 
for one month after surgery to monitor postoperative complication. 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
3.5 
Statistical Analysis 
To decide whether the localization accuracy, radiation exposure and 
complication rate in the two groups are significantly different, three tests 
are used: 1) independent samples t tests for continuous variables that were 
normally distributed; 2) X2 tests for categorical variables, and 3.) Mann-
Whitney U test for continuous variables that were not normally distributed. 
 Because of the possibility of patients withdraw, intention-to-
treatment (ITT) analysis and efficacy analysis are both performed. ITT 
analysis is conducted for participants who received lung nodule 
localization and subsequent surgery. Efficacy analysis is only performed 
for patients who received lung nodule localization according to their 
assignment. All statistical analyses are two-tailed with a significance level 
of 0.05. 
 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
4 STYDT EBROLLMENT AND WITHDRAW 
4.1 
Inclusion Criteria 
Patient scheduled lung nodule resection by VATS is assessed for eligibility. 
The inclusion criteria are as follows.  
(1) The long-axis diameter of the target lung nodule is less than or   equal 
to 20 mm;  
(2) The inner edge of the target nodule is at least 2 cm away from major 
pulmonary arteries or veins to allow secure nodule excision;  
(3) patient’s surgeon in charge must confirm the necessity of preoperative 
lung nodule localization.  
(4) Male or female ≥ 18years of age 
4.2    Exclusion criteria  
(1) There are more than two lung nodules which are needed to be localized 
for simultaneous resection. 
(2) The target nodule is located in the scapula region; and percutaneous 
localizer is impeded by the scapula bone. Therefore transthoracic  
percutaneous lung nodule localization is not suitable for this subset of 
patients.   
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
4.3   Treatment Assignment Procedures  
In order to randomly assign the participants to the two groups, a 
randomization list with 200 numbers was created using blocked 
randomization with a block size of 10. The 200 random numbers are each 
placed in sealed envelopes which are marked with sequential number at the 
cover. 
Patients with scheduled lung resection are evaluated by research 
assistants. If the above criteria are met and patient’s consent to 
participation has also been acquired, then the patient’s information is sent 
to a person who is not involved with the trial by calling. Then, the accorded 
envelop is opened to assign the patient to template- or CT-guided 
localization group.  
Because of the intrinsic property of the trial, no masking procedure 
is performed. After assignment, if the patient is allocated to template-
guided lung nodule localization, research assistant needs to download the 
patients CT data from Picture Archiving and Communication Systems. The 
planned localization route is marked on CT images by patient’s surgeon, 
then the CT data is emailed to designers for template design and printing. 
Because it takes about 6-8 hours for template production, all enrolled 
patents have to give consent to participate at least one day before the 
scheduled surgery.  

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
 
4.6   Reasons for Withdrawal after Randomization 
When patients are firstly approached by research assistants, they are 
informed that they have the right to withdraw their consent to participate 
at any stage of the trial without influence on their medical care. Therefore, 
patients with intended withdrawal after randomization is excluded from the 
study. 
  As the decision of lung nodule localization need to be made at more 
than one day before the scheduled surgery to allow for template production, 
there is the possibility of premature randomization, which is that the 
assigned patient might not suitable for lung resection after preoperative 
assessment. Patent whose scheduled lung resection is cancelled is 
withdrawn from the analysis. 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
5 STUDY INTERVENTION 
All lung nodule localization procedures in both groups are performed 
under the surveillance of a Brilliance 40 CT scanner (Philips Medical 
Systems, Netherlands) by the same practitioner. And, the percutaneous 
transthoracic pulmonary nodule localization is conducted using the 
hookwire localization system (20 gauge, PAJUNK, Germany). 
5.1    Control Group 
 Patients in the CT-guided group received conventional CT-guided 
percutaneous lung nodule localization using a hookwire system. After 
patients were positioned on the examining table of the CT scanner 
(patient’s position was decided based on the location of the target nodule), 
the initial CT scan was conducted through the area of interest using a slice 
thickness of 3 mm. The localizer insertion site was determined by the CT 
gantry laser lights and a metal marker on the skin. The insertion length and 
angle were measured on CT images, and the localizer was then inserted 
without penetrating the pleura. Afterwards, repeated CT scans were taken 
to confirm or redirect the localizer in order to obtain adequate accuracy of 
nodule localization. Based on previous experience, deviations of <2 cm 
between the localizer and the center of the target nodule were considered 
accurate enough to allow for safe nodule localization. After confirmation 
of accurate localizer placement, the practitioner inserted the localizer into 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
the lung parenchyma and removed the cannula of hookwire.  
5.2    Experiment Group 
Patients in the template-guided group underwent template-guided 
percutaneous lung nodule localization using a hookwire. After template 
placement and prior to hookwire insertion, an initial CT scan is obtained to 
pre-evaluate the accuracy of nodule localization. If the deviation is less 
than 2 cm on the initial CT scan, the hookwire is inserted, and the localizer 
is deployed. However, if the deviation >2 cm based on the pre-evaluation 
on the initial CT scan, patients would receive conventional CT-guided 
localization.  
After successful nodule localization, the CT scan is immediately 
obtained in order to evaluate the incidence and severity of the 
pneumothorax and hemorrhage in both groups. Afterwards, patients are 
wheeled back to the unit where they wait for the scheduled surgery. During 
the waiting period, patients are closely observed by nurses, and any 
occurrence of dyspnea and hemoptysis are detailly recorded.  
6.   Outcome Evaluation  
The characteristics of nodule localization, including accuracy of 
nodule localization, procedural length, radiation exposure, and related 
complications are recorded on site by research assistant. Incidence of 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
localizer dislodgement and margin distance reported by frozen section 
analysis are collected during lung resection at the operative room. 
6.1   Measurement of Localization Accuracy 
The accuracy of nodule localization was defined by the deviation 
between the localizer and the center of the target nodule on CT images. 
Because the target nodule and localizer are in the three-dimensional space 
of a patient’s thoracic cage, which may not be seen on the same cut of CT 
scan, it is difficult to precisely measure the deviation directly on the 2D 
images of CT scan. In order to accurately measure the deviation, computer-
aided design (CAD) software is introduced to precisely measure the 
deviation.  
Firstly, patient’s thorax is reconstructed based on CT images upon 
nodule localization. Then the deviation is mathematically calculated using 
the CAD software.  
6.2   Procedural Length 
As the start/end point of lung nodule localization can be arbitrary and 
discrepancy between different researchers, procedural duration was 
derived from CT scan parameters, which is calculated as the time length 
between the initial and final scans. 
 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
6.3   Radiation exposure 
The total amount of radiation exposure that patient receives during 
the lung nodule localization is quantified using dose-length product (DLP). 
And, the DLP value is directly displayed on the screen of the CT scanner 
after the scanning session. In order to estimate the relative amount of 
radiation dose, the effective dose (ED) is also calculated based on the DLP 
values (Radiology;2008;248:995-1003). 
6.4   Complication Related to Nodule Localization 
6.4.1 During lung nodule localization 
All lung nodule localizations are conducted with presence of at least 
two researcher assistants to ensure the obedience of procedure protocol and 
collect complication information onsite. The occurrence of pneumothorax 
and pulmonary hemorrhage is immediately evaluated on the CT scan after 
the deployment of localizer. Other infrequent complications such as 
vasovagal response and hemoptysis are also recorded. 
6.4.2 After localization prior to surgery 
After lung nodule localization, patients are taken into the unit to wait 
for surgery. In this period of time, patients are monitored closely by nurses 
in case of the exacerbation of pneumothorax. And, occurrence of 
hemoptysis and any other discomforts are detailed recorded. 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
6.4.3 During Surgery  
Whether the target nodule is successfully resected by VATS with 
wedge resection is recorded by on-site researchers. During the VATS, the 
occurrence of localizer dislodgement is also recorded. After lung wedge 
resection, the margin distance reported by frozen section analysis is 
collected. 
 
7.  ETHICS AND PROTECTION OF HUMAN SUBJECTS 
7.1 Ethical Standard 
The investigator will ensure that this study is conducted in full 
conformity with the rules set by the Medical Equipment Specification for 
the Quality Control of Clinical Trial (State Food and Drug 
Administration/National 
Health 
and 
Family 
Planning 
Commission/Number twenty-fifth). All personnel involved in the conduct 
of this study have completed human subject protection training. 
7.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and 
all subject materials will be submitted to the IRB (Shanghai pulmonary 
hospital affiliated to Tongji University) for review and approval.  Approval 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
of both the protocol and the consent form must be obtained before any 
subject is enrolled.  Any amendment to the protocol will require review 
and approval by the IRB before the changes are implemented in the study. 
7.3 Informed Consent Process 
Before the participants agree to participate into the trial, Informed 
consent is obtained in the study and continues throughout study 
participation.  Extensive discussion of risks and possible benefits of study 
participation will be provided to subjects. A consent form describing in 
detail the study procedures and related risks would be given to the subject 
before participation. Consent forms will be IRB-approved, and the subject 
is required to read and review the document or have the document read to 
him or her. The investigator or designee will explain the research study in 
detail to the participants and answer any questions that may arise. Subjects 
will sign the informed consent document before any study-related 
assessments or procedures. Subjects will be given the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to 
participate.  They may withdraw consent at any time throughout the course 
of the study.  A copy of the signed informed consent document will be 
given to subjects for their records.  The rights and welfare of the subjects 
will be protected by emphasizing to them that the quality of their clinical 
care will not be adversely compromised if they refuse to participate in this 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
trial. The consent process will be documented in the clinical or research 
record.   
8. DATA STORAGE POLICY  
The principal investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported.  All source 
documents should be completed in a neat, legible manner to ensure 
accurate interpretation of data.  The investigators need to maintain 
adequate case histories of study subjects, including accurate case report 
forms (CRFs) and source documentation. 
Data collection and accurate documentation are the responsibilities 
of the study staff under the supervision of the primary investigator.  All 
source documents, laboratory results and CT images must be reviewed by 
the study team and data entry staff, who will ensure that they are accurate 
and complete. Unanticipated problems and adverse events must be 
reviewed by the primary investigator.   
All the study documents and records should be stored for a minimum 
of 2 years after trial completion, which is required by the Medical 
Equipment Specification for the Quality Control of Clinical Trial (State 
Food and Drug Administration/National Health and Family Planning 

Application of 3D printing technique in small pulmonary nodule localization.           Version:1.0  
Protocol ID: K16-284                                                                                                 01oct2016 
Commission/Number twenty-fifth). No trial documents should be 
deliberately destroyed or damaged without consent of the IRB.