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

Sponsor
St. Joseph's Healthcare Hamilton
Study ID
NCT06638125
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3-Dimensional VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence Mapping — 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.
  • 3-Dimensional Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence Mapping — 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.

Study Details

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.

Key Dates

First listed
Oct 15, 2024
Start date
Dec 1, 2026
Status verified
Jan 2026
Primary completion
Nov 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
89 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Phase I: Feasibility of the operation [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

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