NIR Fluorescence-Guided Surgery for Early Stage Lung Cancer

Overseen By Christine Fahim, PhD(c)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: Allergy to ICG, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed. Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.

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.

Is NIR Fluorescence-Guided Surgery using Indocyanine Green (ICG) safe for humans?

Indocyanine Green (ICG) has been used safely in humans for various medical procedures, including imaging and surgery, with a low risk of adverse effects. It is generally well-tolerated, but as with any medical procedure, there may be some risks involved. ^{1 2 3 4 5}

How is the treatment using indocyanine green (ICG) for early-stage lung cancer different from other treatments?

This treatment uses near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) to help surgeons see and remove lung cancer more precisely during surgery. Unlike traditional methods, it provides real-time visualization of tumors and important structures, potentially leading to more complete cancer removal and better protection of healthy tissue. ^{6 7 8 9 10}

Research Team

Waël C Hanna, MDCM MBA FRCSC

Principal Investigator

St. Joseph's Healthcare Hamilton / McMaster University

Eligibility Criteria

This trial is for adults over 18 with early-stage non-small cell lung cancer (NSCLC), specifically Clinical Stage 1, where the tumor is less than 3 cm and confined to a single segment of the lung. It's not suitable for those allergic to indocyanine green or iodine, nor for pregnant or breastfeeding women without effective birth control.

Inclusion Criteria

My CT scan shows my lung tumor is in one segment, making me eligible for a specific type of surgery.

My tumor is smaller than 3 cm.

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

Exclusion Criteria

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

I am not pregnant, breastfeeding, or able to become pregnant without using birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy using indocyanine green (ICG) fluorescent dye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

1 year

Treatment Details

Interventions

• Indocyanine Green

Trial Overview The study tests a surgical technique called Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy using indocyanine green dye. This aims to help surgeons remove only the affected lung segment instead of an entire lobe, preserving more healthy tissue in patients with small tumors.

Participant Groups

Group I: indocyanine green Experimental Treatment 1 Intervention

Non-toxic, fluorescent dye

Indocyanine Green is already approved in United States, European Union, China, Japan for the following indications:

Approved in United States as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in European Union as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in China as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Approved in Japan as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Findings from Research

A systematic review of 18 studies on neoadjuvant immune checkpoint inhibitors (ICIs) for early-stage non-small-cell lung cancer (NSCLC) suggests that these treatments are generally safe and well tolerated, with low 30-day mortality rates (0% to 5.4%) and no significant adverse events reported as the main cause for surgery cancellations.

Surgery cancellation rates varied widely (0% to 45.8%), primarily due to disease progression rather than treatment-related adverse events, indicating that while ICIs are promising, careful monitoring of disease status is crucial before surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Neoadjuvant Immune Checkpoint Inhibitors on Surgery and Perioperative Complications in Patients With Non-small-cell Lung Cancer: A Systematic Review. Takada, K., Takamori, S., Brunetti, L., et al.[2023]

In a study of 119,146 patients with non-small cell lung cancer (NSCLC) who underwent surgical resection, the overall 30-day mortality rate was found to be 3.4%, with higher rates associated with more complex procedures like pneumonectomy (8.5%).

Factors such as increasing age, male sex, higher comorbidities, and lower facility volume were linked to increased 30-day mortality and longer hospital stays, indicating that these variables can help predict surgical outcomes in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of mortality after surgical management of lung cancer in the National Cancer Database. Rosen, JE., Hancock, JG., Kim, AW., et al.[2022]

In a study of 520 patients undergoing lung resection for Non-Small-Cell Lung Cancer, the overall rate of major perioperative complications was found to be 23.3%, with factors like male gender, hypertension, and reduced lung function (FEV1<75%) identified as significant risk predictors.

A new scoring system, called the Major Perioperative Complications of Lung Resection (MPCLR) score, was developed to predict complications, showing reasonable accuracy with a C-statistic of 0.70 and a high positive predictive value of 88% for scores above 10 points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LUNG RESECTION FOR NON-SMALL-CELL LUNG CANCER - A NEW RISK SCORE TO PREDICT MAJOR PERIOPERATIVE COMPLICATIONS. Veiga Oliveira, P., Cabral, D., Antunes, M., et al.[2022]

In a study of 1041 patients undergoing pulmonary cancer surgery, the presence of any postoperative adverse event, even minor ones, significantly increased the likelihood of a prolonged hospital stay, with higher severity events leading to even longer stays.

Factors such as lower lung diffusion capacity and the use of open thoracotomy were also associated with longer hospital stays, highlighting the importance of preoperative assessments and surgical approaches in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All grades of severity of postoperative adverse events are associated with prolonged length of stay after lung cancer resection. Zhang, Z., Mostofian, F., Ivanovic, J., et al.[2022]

Patients with non-small-cell lung cancer (NSCLC) who have preoperative sarcopenia and a history of smoking are at a higher risk for developing postoperative pulmonary complications and infections after surgery.

Advanced tumor stage, high neutrophil-to-lymphocyte ratio, and the use of traditional open thoracotomy are significant risk factors that negatively impact overall and disease-free survival in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Assessment of the Clinical Risk Factors of Postoperative Adverse Events and Survival in Patients With Non-small-cell Lung Cancer. Chang, BS., Peng, TC., Lue, KH., et al.[2023]

In a study involving 45 patients with thoracic tumors, it was found that different doses of indocyanine green (ICG) optimize fluorescence imaging based on tumor type, with lower doses (2-3 mg/kg) being more effective for non-primary lung cancers and higher doses (4-5 mg/kg) for primary lung cancers.

The study highlights that background fluorescence interference increases with higher ICG doses, which is crucial for determining the optimal dose for effective imaging during surgery, potentially leading to improved surgical outcomes and cost reductions in future imaging trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. Newton, AD., Predina, JD., Corbett, CJ., et al.[2020]

Indocyanine green inhalation was successfully used to enhance intraoperative visualization of pulmonary ground-glass opacity during thoracoscopic wedge resection, allowing for precise localization of the tumor.

The use of a near-infrared fluorescence imaging system provided high contrast in delineating the tumor margin, which helped minimize damage to lung function during the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Fluorescence Visualization in Thoracoscopic Surgery. Huang, W., Wang, K., Chen, F., et al.[2023]

Near-infrared fluorescence imaging using indocyanine green (ICG) is beneficial for detecting specific anatomical features during surgeries, including sentinel lymph node mapping and solid tumor identification.

The application of NIR fluorescence imaging in thoracic surgery is currently underexplored, suggesting potential for future developments in this area to enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of near-infrared fluorescence imaging with indocyanine green in thoracic surgery: a literature review. Chiu, CH., Chao, YK., Liu, YH., 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]

Near-infrared (NIR) fluorescence guided surgery, particularly using indocyanine green (ICG), enhances the visibility of anatomical structures during thoracic surgery, potentially leading to more complete cancer resections and better protection of healthy tissues.

The review categorizes NIR fluorescence applications into four areas, including blood supply and lymphatic drainage, highlighting the technique's versatility and its potential to improve patient outcomes and health economics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of indocyanine green based near-infrared fluorescence imaging in thoracic surgery. Zhou, J., Yang, F., Jiang, G., et al.[2022]

References

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

Impact of Neoadjuvant Immune Checkpoint Inhibitors on Surgery and Perioperative Complications in Patients With Non-small-cell Lung Cancer: A Systematic Review. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of mortality after surgical management of lung cancer in the National Cancer Database. [2022]

3. Portugal pubmed.ncbi.nlm.nih.gov

LUNG RESECTION FOR NON-SMALL-CELL LUNG CANCER - A NEW RISK SCORE TO PREDICT MAJOR PERIOPERATIVE COMPLICATIONS. [2022]

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

All grades of severity of postoperative adverse events are associated with prolonged length of stay after lung cancer resection. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Comprehensive Assessment of the Clinical Risk Factors of Postoperative Adverse Events and Survival in Patients With Non-small-cell Lung Cancer. [2023]

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

Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Intraoperative Fluorescence Visualization in Thoracoscopic Surgery. [2023]

8. China pubmed.ncbi.nlm.nih.gov

Clinical use of near-infrared fluorescence imaging with indocyanine green in thoracic surgery: a literature review. [2022]

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

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

10. China pubmed.ncbi.nlm.nih.gov

Applications of indocyanine green based near-infrared fluorescence imaging in thoracic surgery. [2022]