Pulmonary Nodule, SolitaryNCT04056923
3D Printing for Nodule Localization
A study testing 3D-printing guided, CT-guided and Indocyanine Green in people with Pulmonary Nodule, Solitary and Lung Cancer, run by Wen-zhao ZHONG at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary, Lung Cancer
- What is being tested?
- 3D-printing guided, CT-guided and Indocyanine Green
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Nodule, Solitary, Lung Cancer
- Being tested
- 3D-printing guided, CT-guided, Indocyanine Green, Methylene blue, Preoperative
- Keywords
- Pulmonary Nodules, Lung Neoplasms, Computed Tomography, Three-Dimensional Printing
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printing guidedProcedure or surgery
3D printed navigational template guided
CT-guidedProcedure or surgery
CT-guided
Indocyanine GreenDrug
The results are shown by comparison of different colors.
Methylene blueDrug
The results are shown by comparison of different colors.
PreoperativeProcedure or surgery
Preoperative localization.
IntraoperativeProcedure or surgery
Intraoperative localization.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed template-guided(3D-G) | Experimental | Intraoperative 3D-G methylene blue dye marking in the operating room Receives: 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 Receives: Procedure: CT-guided; Drug: Indocyanine Green; Procedure: Preoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Jan 2018
- Primary completion7 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wen-zhao ZHONG
- Collaborators
- Zhuhai Seine Technology Co., Ltd, Zhuhai city, China
- Responsible party
- Sponsor-investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056923
- Sponsor's protocol ID
- 3D printing navigation
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT04056923
- Acronym / sponsor ID
- 3D printing navigation
- Conditions
- Pulmonary Nodule, Solitary, Lung Cancer
- Keywords
- Pulmonary Nodules, Lung Neoplasms, Computed Tomography, Three-Dimensional Printing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Wen-zhao ZHONG
- Collaborators
- Zhuhai Seine Technology Co., Ltd, Zhuhai city, China
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed template-guided(3D-G) | Experimental | Procedure: 3D-printing guided, Drug: Methylene blue, Procedure: IntraoperativeIntraoperative 3D-G methylene blue dye marking in the operating room |
| CT-guided(CT-G) | Active comparator | Procedure: CT-guided, Drug: Indocyanine Green, Procedure: PreoperativePreoperative localization is performed by CT-G indocyanine green marking in the radiology department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printing guided3D printed navigational template guided | Procedure or surgery | 3D-printed template-guided(3D-G) |
| CT-guidedCT-guided | Procedure or surgery | CT-guided(CT-G) |
| Indocyanine GreenThe results are shown by comparison of different colors. | Drug | CT-guided(CT-G) |
| Methylene blueThe results are shown by comparison of different colors. | Drug | 3D-printed template-guided(3D-G) |
| PreoperativePreoperative localization. | Procedure or surgery | CT-guided(CT-G) |
| IntraoperativeIntraoperative localization. | Procedure or surgery | 3D-printed template-guided(3D-G) |
Primary outcome
Localization distance
Time frame: Day of surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printing guided, CT-guided and Indocyanine Green in people with Pulmonary Nodule, Solitary and Lung Cancer, run by Wen-zhao ZHONG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localization distance (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.