Non Small Cell Lung CancerPhase 1/2NCT06638125
3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial
A Phase 1/2 study testing 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping and 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping in people with Non Small Cell Lung Cancer, 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
- What is being tested?
- 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping and 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 31 Dec 2028
- 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
- Age >/= 18 years
- 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.
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
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Yogita S Patel, 905-522-1155 ext. 35096, patelys@mcmaster.ca
Waël C Hanna, MDCM, MBA, FRCSC
About this study
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 virtual reality (VR) anatomical planning (Elucis) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Elucis-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.
If successful, this project will establish a novel operation that has the potential of increasing the rates of success for segmental resection. This will allow for further research that will externally validate this technique and ensure that it is reproducible in other centres by other surgeons. As segmental resection is the new standard of care for surgical management of early-stage NSCLC, and because 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.
Equally importantly, the investigators believe that this method will enable them to develop a new way of teaching lung resections, in a manner that is more effective for learners. Further research on the role of VR in teaching lung cancer surgery will very likely be a downstream effect of developing this surgical method.
Read the detailed description
Segmental resection is the new standard of care for early-stage non-small cell lung cancer (NSCLC). However, minimally invasive segmental resection is very difficult to perform, due to high inconsistency and variation in segmental anatomy, and the lack of clearly visible tissue planes between segments (intersegmental planes). The investigators have demonstrated that the rate of successful completion of a segmental resection is only 60%. As such, segmental resections are unlikely to become widely adopted by surgeons outside of centres of high volume expertise, unless an adjunct to facilitate and improve the success rate of this operation is developed. In this trial, the investigators propose to use 3-dimensional (3D) virtual reality (VR) modelling to plan, simulate, and execute segmental resections. The investigators believe that this adjunct will improve the rate of successful completion of this operation.
This submission proposes a novel operation for segmental resections of the lung. Segmental resections are extremely difficult to perform because of the high rate of anatomical variations in segmental anatomy, and the lack of visible tissue planes between segments. In the largest prospective series on segmental resection, the investigators demonstrated that the rate of completion was only 60%. The investigators therefore conducted a subsequent trial utilizing 3D preoperative anatomical planning (Synapse 3D) in conjunction with intraoperative NIF-mapping using intravascular ICG in order to increase the rate of successful completion of a segmental resection. However, planned interim analyses has shown that there is no difference in the rate of successful completion of a segmental resection using Synapse 3D or NIF. This is likely the case because the investigators are using 2D models to plan a 3D operation. In this submission, the investigators hypothesize that adding 3D VR preoperative anatomical planning (Elucis) to NIF-guided segmental resection can greatly increase the rate of success of segmental resections. In this Phase I trial, the investigators propose to describe the technical details of this novel operation, and to evaluate it for safety, feasibility, and learning curve. If successful, this would be the first trial to do so, and would allow for further Phase II and III comparative trials to evaluate this operation.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping, 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping
- Keywords
- 3-Dimensional Virtual Reality Modelling, Intravascular Indocyanine Green Fluorescence Mapping, Pulmonary Segmental Resection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence MappingDevice
All patients in Phase I and those randomized to Intervention in Phase II will have preoperative 3D VR reconstructions of their pulmonary anatomy with the target lesion created using the Elucis platform. Segment identification and confidence rating will be collected before and after visualizing the 3D VR reconstruction. Intraoperatively, the surgeon will use this 3D VR model as a guide to determine which inflow and outflow vessels to the involved segment need to be removed. After vascular ligation, a 8mL bolus of ICG solution will be injected into a peripheral vein catheter by anesthesia. The surgeon will mark out the segmental plane based on the fluorescence pattern seen on the infrared mode of the robotic camera. The surgeon will then perform the pulmonary resection and the resected non-fluorescent lung segment will be extracted from the body cavity. Study patients will receive routine postoperative care as non-study patients and will be followed until the 3-4-week mark.
3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence MappingDevice
The patients that are randomized to Control in Phase II will undergo the same intervention as above, but instead of using Elucis for 3D VR reconstructions, Synapse 3D will be used for 3D reconstructions.
| Study group | Role | What they receive |
|---|---|---|
| 3D VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping | Experimental | All patients in Phase I and those randomized to Intervention in Phase II will have preoperative 3D VR reconstructions of their pulmonary anatomy with the target lesion created using the Elucis platform. Receives: Device: 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping |
| 3D Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping | Active comparator | The patients that are randomized to Control in Phase II will undergo the same intervention as above, but instead of using Elucis for 3D VR reconstructions, Synapse 3D will be used for 3D reconstructions. Receives: Device: 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Feasibility of the operation
Based on the proportion of completed minimally invasive segmental resections. A rate of 60%, similar to the established current standard, will be considered adequate.
Measured: Through study completion, an average of 2 years
Phase I: Safety of the operation
Based on rates of perioperative complications within 30-days of surgery, as defined by the Ottawa Thoracic Morbidity \& Mortality (TMNM) System.
Measured: 30-days from date of surgery
Phase I: Surgeon's learning curve
Evaluated using CUSUM analysis of operative time and successful segmentectomy completion rate over time.
Measured: Through study completion, an average of 2 years
Phase II: Rate of conversion to robotic lobectomy in each arm
Evaluated based on the proportion of minimally invasive segmental resections converted to robotic lobectomy in each arm.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I is a single centre, prospective, clinical trial evaluating the safety, feasibility, and learning curve of adding 3D VR anatomical reconstructions and real-time intraoperative mapping using the Elucis platform to NIF-guided targeted segmental resection. Phase II is a single centre, prospective, randomized controlled trial evaluating if this novel operation (Intervention) can increase the rate of successful completion of a segmental resection when compared to Synapse 3D with intraoperative NIF-mapping using intravascular ICG (Control). Patients who are scheduled to undergo robotic pulmonary segmental resection at St. Joseph's Healthcare Hamilton will qualify for inclusion in the study. Exclusion criteria will be patients with tumors \> 3 cm or those with clinical evidence of N1 or N2 disease on preoperative imaging.
- Masking
- None (open label)
- Enrolment
- 89 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
- NCT06638125
- Sponsor's protocol ID
- 3DVRSegmentectomy
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2024
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial
- ClinicalTrials.gov ID
- NCT06638125
- Acronym / sponsor ID
- 3DVRSegmentectomy
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- 3-Dimensional Virtual Reality Modelling, Intravascular Indocyanine Green Fluorescence Mapping, Pulmonary Segmental Resection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (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 virtual reality (VR) anatomical planning (Elucis) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Elucis-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.
If successful, this project will establish a novel operation that has the potential of increasing the rates of success for segmental resection. This will allow for further research that will externally validate this technique and ensure that it is reproducible in other centres by other surgeons. As segmental resection is the new standard of care for surgical management of early-stage NSCLC, and because 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.
Equally importantly, the investigators believe that this method will enable them to develop a new way of teaching lung resections, in a manner that is more effective for learners. Further research on the role of VR in teaching lung cancer surgery will very likely be a downstream effect of developing this surgical method.
Detailed description
Segmental resection is the new standard of care for early-stage non-small cell lung cancer (NSCLC). However, minimally invasive segmental resection is very difficult to perform, due to high inconsistency and variation in segmental anatomy, and the lack of clearly visible tissue planes between segments (intersegmental planes). The investigators have demonstrated that the rate of successful completion of a segmental resection is only 60%. As such, segmental resections are unlikely to become widely adopted by surgeons outside of centres of high volume expertise, unless an adjunct to facilitate and improve the success rate of this operation is developed. In this trial, the investigators propose to use 3-dimensional (3D) virtual reality (VR) modelling to plan, simulate, and execute segmental resections. The investigators believe that this adjunct will improve the rate of successful completion of this operation.
This submission proposes a novel operation for segmental resections of the lung. Segmental resections are extremely difficult to perform because of the high rate of anatomical variations in segmental anatomy, and the lack of visible tissue planes between segments. In the largest prospective series on segmental resection, the investigators demonstrated that the rate of completion was only 60%. The investigators therefore conducted a subsequent trial utilizing 3D preoperative anatomical planning (Synapse 3D) in conjunction with intraoperative NIF-mapping using intravascular ICG in order to increase the rate of successful completion of a segmental resection. However, planned interim analyses has shown that there is no difference in the rate of successful completion of a segmental resection using Synapse 3D or NIF. This is likely the case because the investigators are using 2D models to plan a 3D operation. In this submission, the investigators hypothesize that adding 3D VR preoperative anatomical planning (Elucis) to NIF-guided segmental resection can greatly increase the rate of success of segmental resections. In this Phase I trial, the investigators propose to describe the technical details of this novel operation, and to evaluate it for safety, feasibility, and learning curve. If successful, this would be the first trial to do so, and would allow for further Phase II and III comparative trials to evaluate this operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I is a single centre, prospective, clinical trial evaluating the safety, feasibility, and learning curve of adding 3D VR anatomical reconstructions and real-time intraoperative mapping using the Elucis platform to NIF-guided targeted segmental resection. Phase II is a single centre, prospective, randomized controlled trial evaluating if this novel operation (Intervention) can increase the rate of successful completion of a segmental resection when compared to Synapse 3D with intraoperative NIF-mapping using intravascular ICG (Control). Patients who are scheduled to undergo robotic pulmonary segmental resection at St. Joseph's Healthcare Hamilton will qualify for inclusion in the study. Exclusion criteria will be patients with tumors > 3 cm or those with clinical evidence of N1 or N2 disease on preoperative imaging.
| Arm | Type | Receives |
|---|---|---|
| 3D VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping | Experimental | Device: 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence MappingAll patients in Phase I and those randomized to Intervention in Phase II will have preoperative 3D VR reconstructions of their pulmonary anatomy with the target lesion created using the Elucis platform. |
| 3D Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping | Active comparator | Device: 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence MappingThe patients that are randomized to Control in Phase II will undergo the same intervention as above, but instead of using Elucis for 3D VR reconstructions, Synapse 3D will be used for 3D reconstructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >/= 18 years
- 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 (2 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.
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 |
|---|---|---|
| 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence MappingAll patients in Phase I and those randomized to Intervention in Phase II will have preoperative 3D VR reconstructions of their pulmonary anatomy with the target lesion created using the Elucis platform. Segment identification and confidence rating will be collected before and after visualizing the 3D VR reconstruction. Intraoperatively, the surgeon will use this 3D VR model as a guide to determine which inflow and outflow vessels to the involved segment need to be removed. After vascular ligation, a 8mL bolus of ICG solution will be injected into a peripheral vein catheter by anesthesia. The surgeon will mark out the segmental plane based on the fluorescence pattern seen on the infrared mode of the robotic camera. The surgeon will then perform the pulmonary resection and the resected non-fluorescent lung segment will be extracted from the body cavity. Study patients will receive routine postoperative care as non-study patients and will be followed until the 3-4-week mark. | Device | 3D VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping |
| 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence MappingThe patients that are randomized to Control in Phase II will undergo the same intervention as above, but instead of using Elucis for 3D VR reconstructions, Synapse 3D will be used for 3D reconstructions. | Device | 3D Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping |
Primary outcome
Phase I: Feasibility of the operation
Time frame: Through study completion, an average of 2 years
Based on the proportion of completed minimally invasive segmental resections. A rate of 60%, similar to the established current standard, will be considered adequate.
Phase I: Safety of the operation
Time frame: 30-days from date of surgery
Based on rates of perioperative complications within 30-days of surgery, as defined by the Ottawa Thoracic Morbidity \& Mortality (TMNM) System.
Phase I: Surgeon's learning curve
Time frame: Through study completion, an average of 2 years
Evaluated using CUSUM analysis of operative time and successful segmentectomy completion rate over time.
Phase II: Rate of conversion to robotic lobectomy in each arm
Time frame: Through study completion, an average of 2 years
Evaluated based on the proportion of minimally invasive segmental resections converted to robotic lobectomy in each arm.
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.
- 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 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping and 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping in people with Non Small Cell Lung Cancer, 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 4 inclusion and 2 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: opening soon, 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 Yogita S Patel (905-522-1155 ext. 35096, patelys@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Feasibility of the operation (time frame: Through study completion, an average of 2 years). The study lists 4 primary outcomes in all. 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 2 Feb 2026.