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

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Nov 30, 2027 to Nov 30, 2028
    • Start date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    v5
  2. Notable Start date: Jul 1, 2025 to Dec 1, 2025
    • Primary completion date: Jun 30, 2027 to Nov 30, 2027
    • Study completion date: Jun 30, 2027 to Dec 31, 2027
    v4
  3. Notable Start date: May 1, 2025 to Jul 1, 2025
    • Primary and study completion dates: Apr 30, 2027 to Jun 30, 2027
    v3
  4. Notable Start date: Jan 1, 2025 to May 1, 2025
    • Primary and study completion dates: Dec 31, 2026 to Apr 30, 2027
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06638125
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions
(from sponsor)
Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 89 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov