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

NCT06638125 | Not Yet Recruiting Phase 1

• 1 other identifier: 3DVRSegmentectomy
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

3-Dimensional Virtual Reality Modelling; Intravascular Indocyanine Green Fluorescence Mapping; Pulmonary Segmental Resection

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through study completion, an average of 2 years

Study Arms (2)

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.

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Waël C Hanna, MDCM, MBA, FRCSC

  St. Joseph's Healthcare Hamilton / McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yogita S Patel

CONTACT

905-522-1155; patelys@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division, Thoracic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 15, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)