Non-small Cell Lung CancerPhase 1/2NCT03953144
Synapse 3D With Intravascular Indocyanine Green
A Phase 1/2 study testing Synapse 3D Lung Modelling and IC-Green (ICG) in people with Non-small Cell Lung Cancer and Primary Neoplasm, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Primary Neoplasm
- What is being tested?
- Synapse 3D Lung Modelling and IC-Green (ICG)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2022to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Tumour size <3 cm
- Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
- CT-imaging confirming that the tumour is confined to one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
Who cannot join
- Hypersensitivity or allergy to ICG, sodium iodide, or iodine
- Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control.
- Patients with clinical evidence of N1 or N2 disease on preoperative imaging
- Pulmonary Function tests demonstrating Forced Expiratory Volume in 1s (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) less than or equal to 30% of predicted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Yogita S Patel, BSc, 905-522-1155 ext. 35096, patelys@mcmaster.ca
Wael C. Hanna, MDCM, MBA, FRCSC
About this study
Official title: Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial
With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.
Read the detailed description
Lungs are made up of individual lobes. When a lung cancer tumour is found in one of these lobes, the surgeon often performs a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue
For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a Segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. Research shows that a segmentectomy can result in less blood loss, shorter operation time, less days of having a chest tube, and a shorter hospital stay, compared to a lobectomy.
With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed in order to safely complete the segmentectomy. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.
In response to these challenges, our surgical group has developed the technique of using Near-Infrared Fluorescence (NIF) mapping with intravascular indocyanine green (ICG) dye injection. With the aid of an infrared camera the surgeon is able to see the segment within a lobe of lung after injection of the ICG dye, allowing for a more accurate segmentectomy. We recently reported a 60% success rate of segmental resections with the use of ICG and NIF-guided surgical resection. However, a limitation to this technique is that the segmental anatomy can only be seen during the operation and only after cutting the blood vessels.
The introduction of 3D reconstruction and virtual modeling provides a new way to locate lesions accurately within a segment and plan the appropriate operation before the actual surgery occurs. Synapse 3D (Mississauga, Canada) is a 3D modelling technology that is capable of producing a detailed 3D virtual model of a patient's lung based on Computed Tomography (CT) scans. It has been shown to be safe and feasible in performing segmental pulmonary resections on a robotic platform. In this study, we propose a new operation that uses 3D anatomical planning before the surgery (Synapse 3D) and real-time NIF-mapping at the time of surgery using ICG dye, which we believe will greatly increase the likelihood of a successful segmentectomy. If this new operation is successful, it will help patients save more of their healthy lung tissue when they are undergoing surgery for lung cancer.
- Conditions
- Non-small Cell Lung Cancer, Primary Neoplasm
- Being tested
- Synapse 3D Lung Modelling, IC-Green (ICG)
- Keywords
- Segmentectomy, Lung Cancer, Robotic Surgery, 3D Modelling, CT Imaging, Near-Infrared Fluorescence, IC-GREEN, Surgical Planning, Indocyanine Green, Early-Stage Lung Cancer, Surgical Mapping, Lung Preservation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synapse 3D Lung ModellingDevice
The 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.
IC-Green (ICG)Drug
Also called Indocyanine Green
ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.
| Study group | Role | What they receive |
|---|---|---|
| Synapse 3D Lung Modelling + IC-GREEN Segmentectomy | Experimental | Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus Receives: Device: Synapse 3D Lung Modelling; Drug: IC-Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Resection Conversion Rate
Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy.
Measured: 1 year
Number of Participants with Post Operative Complications
Post operative complications will be reported and measured using the Ottawa Thoracic Morbidity and Mortality Classification of (a) Adverse reactions to ICG dye at the time of surgery and (b) Perioperative complications through study completion.
Measured: 1 year
Secondary outcomes (7)
Anatomical Accuracy of the 3D Lung Model
Anatomical accuracy will be evaluated using the criteria listed in points a-c. A score of 3/3 on these items will indicate success of anatomical accuracy
- Ex-vivo localization of lesions;
- Ex-vivo confirmation of tumor-free margins around lesion;
- Ex-vivo confirmation of adequate anatomical inter-segmental.
Measured: 1 year
Surgeon Confidence
A pre-operative CT scan based, a pre-operative 3D reconstruction based and post segmental resection surgeon confidence score will be obtained on a scale of 1-5:
1 - not at all confident, 2 - somewhat confident, 3 - confident, 4 - very confident, 5 - extremely confident.
Measured: 1 year
Operation Time
Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room.
Measured: 1 year
Conversion to Thoracotomy
Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy. Descriptive analysis of reasons for conversion will also be collected.
Measured: 1 year
Chest Tube Duration
Duration the patient had chest tubes in situ will be measured by collecting the date of surgery and the date the chest tube was removed.
Measured: 1 year
Length of Stay
Duration of hospital length of stay will be measured by collecting the data of admission and the date of discharge.
Measured: 1 year
Estimated Blood Loss
Estimated blood loss will be measured at the time of operation by OR staff.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Dec 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single centre, prospective clinical trial evaluating the safety and feasibility of adding 3D anatomical reconstructions and real-time intraoperative planning using Synapse 3D software added to NIF-guided targeted segmental resection. It is anticipated that 32 participants will be enrolled within a 1-year period. Enrollment will take place at St. Joseph's Healthcare Hamilton. All patients enrolled will be evaluated until their first scheduled follow-up appointment (within 30 days post-surgery).
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
- Investigators
- Waël C Hanna, MDCM, MBA, FRCSC, Principal investigator, St. Joseph's Healthcare Hamilton / McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953144
- Sponsor's protocol ID
- VISION10042019
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2019
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Landreneau RJ, Sugarbaker DJ, Mack MJ, Hazelrigg SR, Luketich JD, Fetterman L, Liptay MJ, Bartley S, Boley TM, Keenan RJ, Ferson PF, Weyant RJ, Naunheim KS. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg. 1997 Apr;113(4):691-8; discussion 698-700. doi: 10.1016/S0022-5223(97)70226-5.
PubMed 9104978Zhao X, Qian L, Luo Q, Huang J. Segmentectomy as a safe and equally effective surgical option under complete video-assisted thoracic surgery for patients of stage I non-small cell lung cancer. J Cardiothorac Surg. 2013 Apr 29;8:116. doi: 10.1186/1749-8090-8-116.
PubMed 23628209Bedetti B, Bertolaccini L, Rocco R, Schmidt J, Solli P, Scarci M. Segmentectomy versus lobectomy for stage I non-small cell lung cancer: a systematic review and meta-analysis. J Thorac Dis. 2017 Jun;9(6):1615-1623. doi: 10.21037/jtd.2017.05.79.
PubMed 28740676Gossot D, Seguin-Givelet A. Anatomical variations and pitfalls to know during thoracoscopic segmentectomies. J Thorac Dis. 2018 Apr;10(Suppl 10):S1134-S1144. doi: 10.21037/jtd.2017.11.87.
PubMed 29785286Mehta M, Patel YS, Yasufuku K, Waddell TK, Shargall Y, Fahim C, Hanna WC. Near-infrared mapping with indocyanine green is associated with an increase in oncological margin length in minimally invasive segmentectomy. J Thorac Cardiovasc Surg. 2019 May;157(5):2029-2035. doi: 10.1016/j.jtcvs.2018.12.099. Epub 2019 Jan 21.
PubMed 30803778Fukuhara K, Akashi A, Nakane S, Tomita E. Preoperative assessment of the pulmonary artery by three-dimensional computed tomography before video-assisted thoracic surgery lobectomy. Eur J Cardiothorac Surg. 2008 Oct;34(4):875-7. doi: 10.1016/j.ejcts.2008.07.014. Epub 2008 Aug 15.
PubMed 18703345Baste JM, Soldea V, Lachkar S, Rinieri P, Sarsam M, Bottet B, Peillon C. Development of a precision multimodal surgical navigation system for lung robotic segmentectomy. J Thorac Dis. 2018 Apr;10(Suppl 10):S1195-S1204. doi: 10.21037/jtd.2018.01.32.
PubMed 29785294Ivanovic J, Al-Hussaini A, Al-Shehab D, Threader J, Villeneuve PJ, Ramsay T, Maziak DE, Gilbert S, Shamji FM, Sundaresan RS, Seely AJ. Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. Ann Thorac Surg. 2011 Feb;91(2):387-93. doi: 10.1016/j.athoracsur.2010.10.035.
PubMed 21256276Pardolesi A, Veronesi G, Solli P, Spaggiari L. Use of indocyanine green to facilitate intersegmental plane identification during robotic anatomic segmentectomy. J Thorac Cardiovasc Surg. 2014 Aug;148(2):737-8. doi: 10.1016/j.jtcvs.2014.03.001. Epub 2014 Mar 5. No abstract available.
PubMed 24680390
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial
- ClinicalTrials.gov ID
- NCT03953144
- Acronym / sponsor ID
- VISION10042019
- Conditions
- Non-small Cell Lung Cancer, Primary Neoplasm
- Keywords
- Segmentectomy, Lung Cancer, Robotic Surgery, 3D Modelling, CT Imaging, Near-Infrared Fluorescence, IC-GREEN, Surgical Planning
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 May 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.
With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.
Detailed description
Lungs are made up of individual lobes. When a lung cancer tumour is found in one of these lobes, the surgeon often performs a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue
For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a Segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. Research shows that a segmentectomy can result in less blood loss, shorter operation time, less days of having a chest tube, and a shorter hospital stay, compared to a lobectomy.
With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed in order to safely complete the segmentectomy. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.
In response to these challenges, our surgical group has developed the technique of using Near-Infrared Fluorescence (NIF) mapping with intravascular indocyanine green (ICG) dye injection. With the aid of an infrared camera the surgeon is able to see the segment within a lobe of lung after injection of the ICG dye, allowing for a more accurate segmentectomy. We recently reported a 60% success rate of segmental resections with the use of ICG and NIF-guided surgical resection. However, a limitation to this technique is that the segmental anatomy can only be seen during the operation and only after cutting the blood vessels.
The introduction of 3D reconstruction and virtual modeling provides a new way to locate lesions accurately within a segment and plan the appropriate operation before the actual surgery occurs. Synapse 3D (Mississauga, Canada) is a 3D modelling technology that is capable of producing a detailed 3D virtual model of a patient's lung based on Computed Tomography (CT) scans. It has been shown to be safe and feasible in performing segmental pulmonary resections on a robotic platform. In this study, we propose a new operation that uses 3D anatomical planning before the surgery (Synapse 3D) and real-time NIF-mapping at the time of surgery using ICG dye, which we believe will greatly increase the likelihood of a successful segmentectomy. If this new operation is successful, it will help patients save more of their healthy lung tissue when they are undergoing surgery for lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single centre, prospective clinical trial evaluating the safety and feasibility of adding 3D anatomical reconstructions and real-time intraoperative planning using Synapse 3D software added to NIF-guided targeted segmental resection. It is anticipated that 32 participants will be enrolled within a 1-year period. Enrollment will take place at St. Joseph's Healthcare Hamilton. All patients enrolled will be evaluated until their first scheduled follow-up appointment (within 30 days post-surgery).
| Arm | Type | Receives |
|---|---|---|
| Synapse 3D Lung Modelling + IC-GREEN Segmentectomy | Experimental | Device: Synapse 3D Lung Modelling, Drug: IC-Green (ICG)Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tumour size <3 cm
- Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
- CT-imaging confirming that the tumour is confined to one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
Key exclusion criteria (4 listed)
- Hypersensitivity or allergy to ICG, sodium iodide, or iodine
- Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control.
- Patients with clinical evidence of N1 or N2 disease on preoperative imaging
- Pulmonary Function tests demonstrating Forced Expiratory Volume in 1s (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) less than or equal to 30% of predicted.
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 |
|---|---|---|
| Synapse 3D Lung ModellingThe 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively. | Device | Synapse 3D Lung Modelling + IC-GREEN Segmentectomy |
| IC-Green (ICG)Also: Indocyanine GreenICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy. | Drug | Synapse 3D Lung Modelling + IC-GREEN Segmentectomy |
Primary outcome
Segmental Resection Conversion Rate
Time frame: 1 year
Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy.
Number of Participants with Post Operative Complications
Time frame: 1 year
Post operative complications will be reported and measured using the Ottawa Thoracic Morbidity and Mortality Classification of (a) Adverse reactions to ICG dye at the time of surgery and (b) Perioperative complications through study completion.
7 secondary outcomes
Anatomical Accuracy of the 3D Lung Model
Time frame: 1 year
Surgeon Confidence
Time frame: 1 year
Operation Time
Time frame: 1 year
Conversion to Thoracotomy
Time frame: 1 year
Chest Tube Duration
Time frame: 1 year
Length of Stay
Time frame: 1 year
Estimated Blood Loss
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 9104978Landreneau RJ, Sugarbaker DJ, Mack MJ, Hazelrigg SR, Luketich JD, Fetterman L, Liptay MJ, Bartley S, Boley TM, Keenan RJ, Ferson PF, Weyant RJ, Naunheim KS. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg. 1997 Apr;113(4):691-8; discussion 698-700. doi: 10.1016/S0022-5223(97)70226-5.
- Background: PubMed 23628209Zhao X, Qian L, Luo Q, Huang J. Segmentectomy as a safe and equally effective surgical option under complete video-assisted thoracic surgery for patients of stage I non-small cell lung cancer. J Cardiothorac Surg. 2013 Apr 29;8:116. doi: 10.1186/1749-8090-8-116.
- Background: PubMed 28740676Bedetti B, Bertolaccini L, Rocco R, Schmidt J, Solli P, Scarci M. Segmentectomy versus lobectomy for stage I non-small cell lung cancer: a systematic review and meta-analysis. J Thorac Dis. 2017 Jun;9(6):1615-1623. doi: 10.21037/jtd.2017.05.79.
- Background: PubMed 29785286Gossot D, Seguin-Givelet A. Anatomical variations and pitfalls to know during thoracoscopic segmentectomies. J Thorac Dis. 2018 Apr;10(Suppl 10):S1134-S1144. doi: 10.21037/jtd.2017.11.87.
- Background: PubMed 30803778Mehta M, Patel YS, Yasufuku K, Waddell TK, Shargall Y, Fahim C, Hanna WC. Near-infrared mapping with indocyanine green is associated with an increase in oncological margin length in minimally invasive segmentectomy. J Thorac Cardiovasc Surg. 2019 May;157(5):2029-2035. doi: 10.1016/j.jtcvs.2018.12.099. Epub 2019 Jan 21.
- Background: PubMed 18703345Fukuhara K, Akashi A, Nakane S, Tomita E. Preoperative assessment of the pulmonary artery by three-dimensional computed tomography before video-assisted thoracic surgery lobectomy. Eur J Cardiothorac Surg. 2008 Oct;34(4):875-7. doi: 10.1016/j.ejcts.2008.07.014. Epub 2008 Aug 15.
- Background: PubMed 29785294Baste JM, Soldea V, Lachkar S, Rinieri P, Sarsam M, Bottet B, Peillon C. Development of a precision multimodal surgical navigation system for lung robotic segmentectomy. J Thorac Dis. 2018 Apr;10(Suppl 10):S1195-S1204. doi: 10.21037/jtd.2018.01.32.
- Background: PubMed 21256276Ivanovic J, Al-Hussaini A, Al-Shehab D, Threader J, Villeneuve PJ, Ramsay T, Maziak DE, Gilbert S, Shamji FM, Sundaresan RS, Seely AJ. Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. Ann Thorac Surg. 2011 Feb;91(2):387-93. doi: 10.1016/j.athoracsur.2010.10.035.
- Background: PubMed 24680390Pardolesi A, Veronesi G, Solli P, Spaggiari L. Use of indocyanine green to facilitate intersegmental plane identification during robotic anatomic segmentectomy. J Thorac Cardiovasc Surg. 2014 Aug;148(2):737-8. doi: 10.1016/j.jtcvs.2014.03.001. Epub 2014 Mar 5. No abstract available.
- 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.
Waël C Hanna, MDCM, MBA, FRCSC principal investigator
St. Joseph's Healthcare Hamilton / McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Synapse 3D Lung Modelling and IC-Green (ICG) in people with Non-small Cell Lung Cancer and Primary Neoplasm, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter R. A. Malik, BHSc (Honours) (905-522-1155 ext. 35096, malikpr@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental Resection Conversion Rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953144, which also lists 9 linked publications.
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 2 Feb 2026.