3D VR Modelling for Non-Small Cell Lung Cancer

YS
Overseen ByYogita S Patel
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: St. Joseph's Healthcare Hamilton
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new surgical techniques for treating early-stage non-small cell lung cancer (NSCLC) by using 3D virtual reality (VR) models to plan surgeries. The focus is on making lung surgeries less invasive with VR technology and a special dye, intravascular indocyanine green fluorescence mapping, to guide the surgery. Participants who might be suitable have a small lung tumor (under 3 cm) in an early stage, confined to a single lung segment, making them candidates for segmental resection. The study compares two different 3D modeling tools to determine which one best prepares surgeons before the procedure. The ultimate goal is to make lung surgeries safer and more effective while finding better ways to teach these techniques to medical professionals. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking advancements in lung cancer surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical technique is safe for patients with early-stage NSCLC?

Previous studies have used 3D virtual reality (VR) modeling combined with indocyanine green dye to plan lung surgeries. This method enhances the visibility of the lung and its blood vessels, enabling surgeons to perform precise operations, which is crucial for treating lung cancer.

Indocyanine green is generally safe and well-tolerated, having been used in many medical procedures to visualize blood flow. Some individuals might experience mild side effects, such as nausea or a rash, but serious reactions are rare.

This trial is in the early stages (Phase 1 and 2), meaning researchers are still assessing the safety and effectiveness of this technique. The testing of this technology indicates confidence in its potential safety for patients.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative 3D VR modeling techniques for non-small cell lung cancer, aiming to enhance the precision and effectiveness of surgeries. Unlike traditional imaging methods, this trial uses advanced 3D virtual reality reconstructions to give surgeons a detailed view of a patient's lung anatomy, which could lead to more accurate removal of cancerous tissues. Additionally, the incorporation of intravascular indocyanine green fluorescence mapping helps to highlight blood vessels and tumors, potentially improving surgical outcomes and reducing complications. This approach not only enhances visualization but also pushes the boundaries of personalized medicine in cancer treatment.

What evidence suggests that 3D VR modelling is effective for non-small cell lung cancer?

This trial will compare two methods of 3D virtual reality (VR) modeling using indocyanine green (ICG) to enhance surgery for early-stage non-small cell lung cancer (NSCLC). One group of participants will receive 3D VR reconstructions using the Elucis platform, while another group will use Synapse 3D for their reconstructions. Research has shown that 3D VR with ICG can create a detailed image of the lung and its blood vessels, aiding surgeons in planning and performing more precise operations. Early results suggest it may lead to better outcomes than traditional methods. The goal is to make surgeries less invasive, potentially benefiting patients who cannot undergo more extensive procedures. Although this technology is still under study, it holds promise for making lung cancer surgeries safer and more accurate.12345

Who Is on the Research Team?

WC

Waël C Hanna, MDCM MBA FRCSC

Principal Investigator

St. Joseph's Healthcare Hamilton / McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage Non-Small Cell Lung Cancer who may benefit from a less invasive surgical technique called segmentectomy, which removes part of the lung. It's especially aimed at those who can't have a full lobectomy due to other health issues.

Inclusion Criteria

My tumor is smaller than 3 cm.
My condition is stage 1 non-small cell lung cancer.
My CT scan shows my lung tumor is small enough for a specific type of surgery.

Exclusion Criteria

Hypersensitivity or allergy to ICG, sodium iodide, or iodine
I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Planning

3D VR anatomical planning using Elucis platform for targeted pulmonary segmental resection

4 weeks

Surgical Intervention

Execution of segmental resections using 3D VR modelling and NIF-guided techniques

1 day (surgery)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including perioperative complications

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • 3-Dimensional Virtual Reality Modelling with Intravascular Indocyanine Green Fluorescence Mapping
Trial Overview The study tests two types of preoperative planning: one using Elucis 3D VR modeling and another using Synapse 3D, both combined with Intravascular Indocyanine Green Fluorescence Mapping to guide robotic segmental resection surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence MappingExperimental Treatment1 Intervention
Group II: 3D Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence MappingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

Published Research Related to This Trial

The study demonstrated that it is feasible to model the positions of primary tumors and lymph nodes in Stage III lung cancer patients using anatomical surrogates, with mean prediction errors ranging from 0.8 to 1.4 mm based on different modeling approaches.
Using inferential modeling with anatomical surrogates can potentially reduce the processing time of 4D CT scans, which may help in creating more personalized treatment margins for patients.
Inferring positions of tumor and nodes in Stage III lung cancer from multiple anatomical surrogates using four-dimensional computed tomography.Malinowski, KT., Pantarotto, JR., Senan, S., et al.[2021]

Citations

3-Dimensional Virtual Reality Modelling With Intravascular ...In this trial, the investigators propose to use 3-dimensional (3D) virtual reality (VR) modelling to plan, simulate, and execute segmental resections. The ...
3-Dimensional Virtual Reality Modelling With Intravascular ...This study will provide the first case series using preoperative 3D virtual reality (VR) anatomical planning (Elucis) added to ICG and NIF-guided robotic ...
3D VR Modelling for Non-Small Cell Lung CancerThis treatment is unique because it uses 3D virtual reality to create a detailed model of the lung and its blood vessels, combined with a special dye ( ...
3-Dimensional Virtual Reality Modelling With - ClinConnectThis clinical trial is studying a new way to perform surgery for patients with early-stage non-small cell lung cancer (NSCLC) using advanced technology.
3-Dimensional Virtual Reality Modelling With Intravascular ...This study will provide the first case series using preoperative 3D virtual reality (VR) anatomical planning (Elucis) added to ICG and NIF-guided robotic ...
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