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

Overseen by Waël C Hanna, MDCM, MBA, FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: Pregnancy, Breastfeeding, N1/N2 disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Synapse 3D + IC-Green for Early-Stage Lung Cancer?

Research shows that using indocyanine green (ICG) in lung surgeries can help guide surgeons by highlighting areas for resection, which may improve surgical precision. Additionally, 3D imaging techniques are being explored to better understand and plan lung cancer surgeries, potentially enhancing treatment outcomes. ^{1 2 3 4 5}

How is the Synapse 3D + IC-Green treatment different from other lung cancer treatments?

This treatment is unique because it combines 3D imaging with indocyanine green (ICG), a dye that helps surgeons see the cancerous area more clearly during surgery, potentially improving the precision of lung cancer removal. ^{1 2 6 7 8}

Research Team

Waël C Hanna, MDCM, MBA, FRCSC

Principal Investigator

St. Joseph's Healthcare Hamilton / McMaster University

Eligibility Criteria

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.

Inclusion Criteria

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

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

My tumor is smaller than 3 cm.

Exclusion Criteria

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

My scans show cancer has spread to nearby lymph nodes.

You are allergic to ICG, sodium iodide, or iodine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Planning

High-resolution CT scan of the chest is performed to create accurate 3D virtual model reconstructions using Synapse 3D for operative planning.

1-2 weeks

Surgical Treatment

Participants undergo segmentectomy using Synapse 3D-guided anatomical planning and real-time NIF-mapping with ICG dye during surgery.

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative complications and recovery, including chest tube duration and length of hospital stay.

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of postoperative complications and anatomical accuracy.

1 year

Treatment Details

Interventions

• IC-Green (ICG) (Other)
• Synapse 3D Lung Modelling (Procedure)
• VisiblePatient™ 3D Lung Modelling (Procedure)

Trial Overview 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.

Participant Groups

Group I: Synapse 3D Lung Modelling + IC-GREEN Segmentectomy Experimental Treatment 2 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

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Dr. Michael Heenan

St. Joseph's Healthcare Hamilton

Chief Executive Officer since 2023

PhD in Business Administration Health Policy Management, MBA in Health Services Management, and Bachelor of Arts from McMaster University

Dr. Sarah Jarmain

St. Joseph's Healthcare Hamilton

Chief Medical Officer

MD

Findings from Research

Patients with inoperable non-small cell lung cancer who received daily cone beam computed tomography (CBCT) imaging during radiation therapy had a significantly lower incidence of grade ≥2 radiation pneumonitis (RP2) compared to those receiving 2-dimensional orthogonal kilovoltage (kV) imaging (24% vs 44%).

The use of CBCT after an initial 4-dimensional computed tomography (4DCT) simulation was associated with a reduced risk of RP2, with an adjusted hazard ratio of 0.43, indicating that this imaging technique may enhance safety in radiation therapy without affecting overall survival or disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Image Guidance With Cone Beam Computed Tomography May Reduce Radiation Pneumonitis in Unresectable Non-Small Cell Lung Cancer. Yegya-Raman, N., Kim, S., Deek, MP., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The model-based technique for measuring lung tumor motion showed a closer correlation to commercial 4DCT scans when using the 5th to 85th percentile breathing amplitude interval, indicating its potential for more accurate clinical simulations.

Model-based images exhibited significantly lower noise levels and fewer artifacts compared to commercial 4DCT, suggesting improved image quality for tumor localization and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of lung tumor motion measured using a model-based 4DCT technique and a commercial protocol. O'Connell, D., Shaverdian, N., Kishan, AU., et al.[2018]

Indocyanine green (ICG) fluorescence imaging demonstrated a high sentinel lymph node (SLN) detection rate of 98% in a study of 100 patients undergoing robotic-assisted hysterectomy for endometrial cancer, indicating its efficacy in improving surgical outcomes.

The use of ICG for SLN mapping is safe and effective, allowing for bilateral detection in 92% of cases and reducing the need for complete lymphadenectomy, which can lower morbidity and operative costs while still providing important staging information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology for endometrial cancer: A prospective study using a surgical algorithm in Indian patients. Somashekhar, SP., Arvind, R., Kumar, CR., et al.[2022]

In a study involving 102 lung cancer patients, NIR-II fluorescence imaging of indocyanine green (ICG) significantly improved the tumor-to-normal-tissue ratio (TNR) compared to NIR-I, indicating better imaging capabilities for detecting lung cancer.

NIR-II imaging also demonstrated superior fluorescence intensity and signal-to-background ratio when lung tissue thickness exceeded 2 mm, suggesting it can penetrate deeper and provide clearer images, enhancing its clinical utility in lung cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Indocyanine Green Fluorescence Imaging in Lung Cancer with Near-Infrared-I/II Windows. Mi, J., Li, C., Yang, F., et al.[2023]

Indocyanine green (ICG) photodynamic therapy (PDT) effectively induces cell death in pancreatic cancer cells, showing significant growth inhibition at doses as low as 10 microg/mL when combined with infrared light exposure.

The combination of ICG and infrared light resulted in nearly total ablation of cancer cells at 20 microg/mL, while neither ICG nor the laser alone caused toxicity, suggesting a promising treatment option with minimal side effects for patients with difficult-to-treat pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infrared laser activation of indocyanine green inhibits growth in human pancreatic cancer. Tseng, WW., Saxton, RE., Deganutti, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy of transbronchial indocyanine green instillation for fluorescent-guided wedge resection. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Sentinel node navigation surgery using indocyanine green in patients with lung cancer. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Daily Image Guidance With Cone Beam Computed Tomography May Reduce Radiation Pneumonitis in Unresectable Non-Small Cell Lung Cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Inferring positions of tumor and nodes in Stage III lung cancer from multiple anatomical surrogates using four-dimensional computed tomography. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of lung tumor motion measured using a model-based 4DCT technique and a commercial protocol. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology for endometrial cancer: A prospective study using a surgical algorithm in Indian patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative Study of Indocyanine Green Fluorescence Imaging in Lung Cancer with Near-Infrared-I/II Windows. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Infrared laser activation of indocyanine green inhibits growth in human pancreatic cancer. [2019]