← Back to Search

Procedure

3D VR Modelling for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Waël C Hanna, MDCM, MBA, FRCSC

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumour size < 3 cm

Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)

Must not have

Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop new surgical techniques using preoperative 3D virtual reality (VR) anatomical planning to facilitate minimally invasive pulmonary segmentectomy for patients with early-stage lung cancer. The goal

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on surgical techniques rather than medication, side effects are related to surgery risks such as bleeding, infection, or complications from anesthesia rather than typical drug side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My tumor is smaller than 3 cm.

Select...

My condition is stage 1 non-small cell lung cancer.

Select...

I am 18 years old or older.

Select...

My CT scan shows my lung tumor is small enough for a specific type of surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Feasibility of the operation

Phase I: Safety of the operation

Phase I: Surgeon's learning curve

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 3D VR Modelling (Elucis) with Intravascular Indocyanine Green Fluorescence MappingExperimental Treatment1 Intervention

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 II: 3D Modelling (Synapse 3D) with Intravascular Indocyanine Green Fluorescence MappingActive Control1 Intervention

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.

0 / 5Eligibility criteria met