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

Overseen By Peter R. A. Malik, BHSc (Honours)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: St. Joseph's Healthcare Hamilton

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical method for early-stage lung cancer using 3D planning and special dyes. The aim is to create a less invasive surgery that removes only the affected lung part, potentially benefiting patients with small tumors. The trial employs tools like Synapse 3D and IC-Green (a type of dye) to help doctors see and remove the tumor more precisely. Suitable candidates for this trial are those with a small lung tumor (less than 3 cm) confined to one lung section. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative surgical approach.

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 early-stage lung cancer patients?

Research shows that using Synapse 3D lung modeling with IC-Green dye is a novel approach. Limited safety information exists because this study is among the first to combine these technologies for lung surgery. However, IC-Green has been used in other medical procedures and is generally well-tolerated, with only mild side effects such as nausea or allergic reactions reported. While there is limited information on Synapse 3D, it creates 3D images of the lungs, a non-invasive and considered safe method. As this study is in the early stages, its primary goal is to gather detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines advanced 3D lung modeling with a precise surgical technique for treating early-stage lung cancer. Unlike standard treatments, which often rely on traditional imaging and surgery methods, this approach uses high-resolution 3D virtual models to guide the surgeon in removing only the affected lung segment. This precision is further enhanced by the use of IC-Green, a special dye that helps surgeons visualize and isolate the cancerous area during surgery. This method aims to improve surgical accuracy and potentially reduce recovery time and complications, offering a more targeted and less invasive option for patients.

What evidence suggests that Synapse 3D and IC-Green are effective for early-stage lung cancer?

In this trial, participants will receive a combination of Synapse 3D lung modeling and indocyanine green (ICG) during surgery for early-stage lung cancer. Research has shown that Synapse 3D enables surgeons to view the lung in three dimensions, enhancing surgical planning and execution. This method often results in less blood loss, shorter surgeries, and quicker recoveries. ICG, a dye, highlights specific lung areas during surgery, increasing precision. Studies indicate that ICG successfully highlights target areas in up to 94% of cases, aiding in the accurate removal of cancerous tissue. Together, these tools offer promising improvements in surgical success and patient recovery for early-stage lung cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

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 (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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

In a study involving 28 patients, the combination of 3D image analysis and transbronchial indocyanine green (ICG) instillation successfully guided lung wedge resections, achieving a 100% success rate in including the entire targeted tumor in the resected specimens.

The use of ICG allowed for clear visualization of surgical margins, ensuring that all specimens had negative margins for malignant cells, which may reduce the risk of local recurrence after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of transbronchial indocyanine green instillation for fluorescent-guided wedge resection. Sekine, Y., Koh, E., Hoshino, H.[2022]

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]

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]

Sentinel node navigation surgery (SNNS) using indocyanine green (ICG) was successfully performed in 100% of 38 patients with stage cN0 lung cancer, demonstrating its effectiveness in identifying sentinel lymph nodes (LNs).

The sentinel nodes accurately predicted the metastatic status of lymph nodes in 97% of cases, indicating that this technique can be a reliable method for assessing cancer spread in lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node navigation surgery using indocyanine green in patients with lung cancer. Ito, N., Fukuta, M., Tokushima, T., et al.[2015]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9357917/

How effective is indocyanine green (ICG) in localization of ... Recent evidence demonstrates lower lung cancer mortality among high risk population who undergo volume-based, low-dose computed tomographic (CT) ...

2. jtcvstechniques.org jtcvstechniques.org/article/S2666-2507(25)00223-8/fulltext

Feasibility of intraoperative indocyanine green injection to ... Despite surgical resection and mediastinal lymph node dissection, 34% of patients with stage IB to IIB non–small cell lung cancer demonstrate recurrence ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666250725002238

Lung Cancer Feasibility of intraoperative indocyanine ... Despite surgical resection and mediastinal lymph node dissection, 34% of patients with stage IB to IIB non–small cell lung cancer demonstrate recurrence ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10377801/

Analysis Based on Solid Component of Lung Nodule - PMC Therefore, this study may provide guidance regarding ICG use for lung cancer detection, especially early-stage lung cancer. Abstract. ICG ...

5. tlcr.amegroups.org tlcr.amegroups.org/article/view/84559/html

The use of intravenous indocyanine green in minimally ... After administration of intravenous ICG, visualization of the ISP is successful in up to 94% of cases, even after administration of a low dose (0.05 mg/kg) of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03953144

Synapse 3D With Intravascular Indocyanine Green This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date ...

7. clinicaltrial.be clinicaltrial.be/en/details/21507?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Synapse 3D With Intravascular Indocyanine Green - Clinica... Synapse 3D (Mississauga, Canada) is a 3D modelling technology that is capable of producing a detailed 3D virtual model of a patient's lung based ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03953144/synapse-3d-with-intravascular-indocyanine-green

Synapse 3D With Intravascular Indocyanine Green This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03953144?tab=history&a=3

Record History | ver. 3: 2020-03-19 | NCT03953144 This study is a single centre, prospective clinical trial evaluating the safety and feasibility of adding 3D anatomical reconstructions and real-time ...

10. ancora.ai ancora.ai/en/details/NCT03953144

Synapse 3D With Intravascular Indocyanine Green This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date ...