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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help surgeons remove small lung cancer tumors while preserving healthy lung tissue. The study uses a special dye, Indocyanine Green (ICG), and a camera to identify the lung area that requires removal. This approach could result in less lung tissue being removed compared to traditional surgery, benefiting patients with early-stage lung cancer. Suitable candidates for this trial have small tumors (less than 3 cm) confined to one lung segment and have been diagnosed with early-stage non-small cell lung cancer. 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 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 technique is safe for lung cancer surgery?

Research has shown that indocyanine green (ICG) is usually safe for people. Many studies have used ICG injections to detect lung cancer and found it safe. One study found that using CT scans to guide ICG injections for lung procedures was both practical and safe. Another study demonstrated that using ICG during lung surgeries was safe and accurate. Overall, these findings suggest that ICG is a safe choice for surgeries, such as those for early-stage lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using indocyanine green in the treatment of early-stage lung cancer because it offers a unique approach to surgery. Unlike standard treatments that rely heavily on imaging and surgeon expertise to detect cancerous tissues, indocyanine green is a non-toxic, fluorescent dye that illuminates cancer cells during surgery. This fluorescence-guided technique allows for more precise removal of tumors, potentially leading to better outcomes and fewer complications. Additionally, this method could improve the surgeon's ability to distinguish between healthy and cancerous tissue, potentially preserving more healthy lung tissue.

What evidence suggests that NIR fluorescence-guided surgery is effective for early-stage lung cancer?

Research has shown that indocyanine green (ICG) aids surgeons in identifying precise lung sections for removal during surgeries. In this trial, participants will receive ICG, a non-toxic, fluorescent dye, to assist in surgery. Studies indicate that ICG can speed up surgeries and reduce blood loss and hospital stays. This is particularly useful in procedures like segmentectomy, which removes only a small part of the lung instead of an entire lobe. By using ICG, surgeons can better preserve lung function and enhance recovery. This method shows promise for treating early-stage lung cancer by maintaining more healthy lung tissue. ^{2 6 7 8 9}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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 (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]

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/S1015958424015720

Review Article The application of indocyanine green ... Application of ICG-FI in thoracoscopic segmentectomy could reduce operation time, IBL presentation time, length of hospital stay, intraoperative blood loss, ...

4. mdpi.com mdpi.com/2072-6694/15/14/3643

Analysis Based on Solid Component of Lung Nodule Multiple studies have performed intravenous injections of indocyanine green (ICG) for lung cancer detection, including primary and metastatic lung cancers.

5. tlcr.amegroups.org tlcr.amegroups.org/article/view/70380/html

Expert consensus on indocyanine green fluorescence ... Precise anatomical lung segmentectomy preserves more lung function (3) and offers a better survival prognosis, especially in elderly patients, ...

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

Analysis Based on Solid Component of Lung Nodule - PMC Multiple studies have performed intravenous injections of indocyanine green (ICG) for lung cancer detection, including primary and metastatic ...

7. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.967897/full

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) ...

8. qims.amegroups.org qims.amegroups.org/article/view/117676/html

Feasibility and safety of computed tomography-guided ... Computed tomography (CT)-guided intrapulmonary injection of ICG for preoperative localization of peripheral pulmonary GGNs is a practical and safe technique.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2949789224000977

Spot On: Indocyanine Green-Soaked Fiducial Markers for ... Interpretation: Our results indicate that ICG-F is a safe and accurate procedure to facilitate lung sparing surgery of otherwise undetectable PPLs immediately ...