3-Dimensional Virtual Reality Modelling With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial

NCT ID: NCT06638125

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-01
• Study Completion Date: 2028-12-31

Brief 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. 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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping

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.

Group Type: EXPERIMENTAL

3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping

Intervention Type: DEVICE

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.

3D Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping

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.

Group Type: ACTIVE_COMPARATOR

3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping

Intervention Type: DEVICE

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.

Interventions

3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping

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.

Intervention Type: DEVICE

3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Wael Hanna

Head of Division, Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waël C Hanna, MDCM, MBA, FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton / McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Yogita S Patel

Role: CONTACT

patelys@mcmaster.ca

905-522-1155 ext. 35096

Facility Contacts

Yogita S Patel

Role: primary

patelys@mcmaster.ca

905-522-1155 ext. 35096

Other Identifiers

3DVRSegmentectomy

Identifier Type: -

Identifier Source: org_study_id