What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include surgical resection, chemotherapy, radiation therapy, and immunotherapy. Surgical resection, especially with advanced techniques like 3D anatomical planning and robotic assistance, can lead to side effects such as pain, infection, and complications related to anesthesia. Chemotherapy often causes nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation therapy can result in skin irritation, fatigue, and esophagitis. Immunotherapy may cause immune-related side effects like rash, colitis, and pneumonitis. Each treatment modality has its own risk profile, and side effects can vary based on individual patient factors.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that focus on targeted therapies and advanced imaging techniques. Notable approvals include pembrolizumab (Keytruda) in combination with pemetrexed and platinum chemotherapy for metastatic nonsquamous NSCLC, and atezolizumab (Tecentriq) in combination with bevacizumab and chemotherapy for first-line treatment of metastatic nonsquamous NSCLC. These treatments enhance precision in targeting cancer cells, similar to the goals of the trial involving preoperative 3D anatomical planning with ICG and NIF-guided robotic segmentectomy, which aims to improve surgical outcomes through enhanced visualization and precision.

What other types of research exist?

Promising novel alternatives for NSCLC treatment in 2024 include: 1) Wireless wearable fluorescence image-guided surgery systems, which provide real-time augmented reality visualization to enhance precision during pulmonary segmentectomy. 2) Advanced robotic-assisted thoracoscopic surgery (RATS) with integrated fluorescence imaging, offering improved accuracy in tumor localization and resection. 3) Hybrid minimally invasive esophagectomy techniques, which combine the benefits of both open and minimally invasive approaches to optimize surgical outcomes. These alternatives aim to improve surgical precision, reduce invasiveness, and enhance patient recovery.

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Synapse 3D + IC-Green for Early-Stage Lung Cancer

Phase 1 & 2

Recruiting

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

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.

Must not have

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

Patients with clinical evidence of N1 or N2 disease on preoperative imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial tests a new method for lung cancer surgery that uses 3D planning and special dye to help surgeons remove only the diseased part of the lung. It aims to help patients keep more of their healthy lung tissue, especially those with early-stage cancer or other health problems.

Who is the study for?

This trial is for individuals with early-stage Non-Small Cell Lung Cancer (NSCLC), specifically those with tumors smaller than 3 cm and confined to one lung segment. It's not suitable for patients allergic to ICG or iodine, pregnant or breastfeeding women, or those without effective birth control. People with certain lung function test results indicating severe impairment are also excluded.

What is being tested?

The study tests a new surgical technique using Synapse 3D preoperative planning combined with IC-Green (ICG) during minimally invasive robotic surgery for lung cancer. The goal is to improve outcomes in pulmonary segmentectomy, which could benefit many patients annually.

What are the potential side effects?

Potential side effects may include reactions related to the use of IC-Green such as allergy symptoms due to sensitivity towards the dye used in imaging. Surgical risks can also be expected from the procedure itself.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

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My tumor is smaller than 3 cm.

Exclusion Criteria

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

Select...

I am not pregnant, breastfeeding, and if able to bear children, I am using effective birth control.

Select...

My scans show cancer has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with Post Operative Complications

Segmental Resection Conversion Rate

Secondary study objectives

Anatomical Accuracy of the 3D Lung Model

Chest Tube Duration

Conversion to Thoracotomy

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Synapse 3D Lung Modelling + IC-GREEN SegmentectomyExperimental Treatment2 Interventions

Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include surgical resection, systemic therapies, and radiation therapy. Surgical resection, such as lobectomy or segmentectomy, physically removes the tumor and is often the first-line treatment for early-stage NSCLC. Advanced techniques like preoperative 3D anatomical planning with ICG and NIF-guided robotic segmentectomy enhance visualization and precision, potentially improving surgical outcomes and reducing complications. Systemic therapies, including chemotherapy, targeted therapy, and immunotherapy, work by attacking cancer cells throughout the body, either by directly killing them or by boosting the immune system's ability to fight cancer. Radiation therapy uses high-energy rays to destroy cancer cells in a specific area. These treatments are crucial for NSCLC patients as they offer multiple avenues to control and potentially eradicate the disease, improving survival rates and quality of life.

Unexpected long survival of brain oligometastatic non-small cell lung cancer (NSCLC) treated with multimodal treatment: a single-center experience and review of the literature.Radiation Therapy for Oligometastatic Non-Small Cell Lung Cancer: Theory and Practice.