SLN Mapping with ICG + NIR Imaging for Esophageal Cancer

Overseen By Smita Sihag, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Severe allergy, Pregnancy, Hepatic dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.

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 using indocyanine green (ICG) dye and near-infrared (NIR) imaging for sentinel lymph node mapping in esophageal cancer?

Research shows that using indocyanine green (ICG) with near-infrared imaging can help identify sentinel lymph nodes in esophageal cancer, which may reduce the need for more invasive procedures. Although results vary, this method is already used in other cancers like breast cancer, suggesting its potential effectiveness. ^{1 2 3 4 5}

Is the use of indocyanine green (ICG) dye for sentinel lymph node mapping generally safe in humans?

Research indicates that indocyanine green (ICG) is generally safe for sentinel lymph node mapping, with studies showing it has a lower rate of false positives and tissue damage compared to other dyes. It is used in various conditions, including breast cancer, and is considered a safe alternative to other methods that may have more side effects. ^{3 6 7 8 9}

How is SLN Mapping with ICG + NIR Imaging different from other treatments for esophageal cancer?

SLN Mapping with ICG (indocyanine green) and NIR (near-infrared) imaging is unique because it uses a special dye and light to help doctors see and map the lymph nodes during surgery, which can help identify cancer spread more accurately. This method is minimally invasive and provides real-time visualization, which is not typically available with standard imaging techniques. ^{2 3 6 10 11}

Research Team

Daniela Molena, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with a specific type of esophageal or esophagogastric junction cancer, who are set to have minimally invasive surgery. It's not for those with severe allergies to iodide/seafood, pregnant/lactating women, patients with widespread cancer (Stage IVB/M1), or those with serious liver/kidney issues.

Inclusion Criteria

My cancer is in the lower part of the esophagus or where it meets the stomach, and I am planning to have surgery to remove it.

I have signed the consent forms for both the study and surgery.

My cancer is at Stage IVA according to the AJCC 8th edition.

Exclusion Criteria

I have a local recurrence and am planning to have surgery to remove my esophagus.

I have had severe liver or kidney problems.

I am not planning to have surgery to remove my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ICG injection and NIR imaging for lymphatic mapping, followed by SLN biopsy during standard completion lymphadenectomy and esophagectomy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Injection of indocyanine green (ICG) dye
• Near-Infrared Image-Guided
• Sentinel Lymph Node (SLN) mapping
• Sentinel Lymph Node (SNL) mapping

Trial Overview The study tests if injecting ICG dye and using NIR imaging can pinpoint the first lymph nodes that cancer might spread to in esophageal or junction cancers. This could let surgeons remove fewer lymph nodes during operations.

Participant Groups

Group I: SLN mapping by NIR with ICG Experimental Treatment 3 Interventions

Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

The new fluorescent agent ICG:MSA showed significantly higher targeting ability for lymph nodes compared to traditional agents, with a fluorescence signal that was more than double that of ICG and ICG:HSA, indicating its potential for better lymph node mapping in esophageal cancer surgery.

ICG:MSA demonstrated improved retention in lymph nodes for up to 3 hours, allowing for more precise and real-time detection of sentinel lymph nodes during surgery, which could help avoid unnecessary invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macrophage-Targeted Indocyanine Green-Neomannosyl Human Serum Albumin for Intraoperative Sentinel Lymph Node Mapping in Porcine Esophagus. Kim, HK., Quan, YH., Oh, Y., et al.[2022]

Indocyanine-green (ICG) imaging for sentinel lymph node mapping in esophageal cancer showed a high detection rate of 89%, indicating its potential effectiveness in identifying lymph nodes during surgery.

The pooled sensitivity for detecting lymph node metastases was 84%, but the specificity was low at 15%, suggesting that while ICG is good at finding nodes, it may not reliably indicate whether they contain cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of Indocyanine-Green Imaging for Sentinel Lymph Node Mapping and Lymph Node Metastasis in Esophageal Cancer: Systematic Review and Meta-Analysis. Jimenez-Lillo, J., Villegas-Tovar, E., Momblan-Garcia, D., et al.[2021]

The study presents a minimally invasive laparoscopic technique for sentinel lymph node (SLN) mapping in women with apparent confined endometrial cancer, utilizing indocyanine green (ICG) and two different fluorescence imaging systems.

Both the PINPOINT and Full HD Image 1S systems are effective for SLN detection, but the PINPOINT system is noted to provide easier and faster identification of SLNs, especially when using its color-segmented fluorescence feature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Typical and Atypical Locations of Sentinel Node Mapping with Indocyanine Green: Comparison of 2 Near-Infrared Fluorescence Systems. Di Martino, G., Reato, C., Verri, D., et al.[2019]

The study demonstrated that using preoperative computed tomographic lymphography (CTLG) combined with intraoperative indocyanine green (ICG) fluorescence imaging (IGFI) allows for accurate identification of sentinel lymph nodes (SLNs) in all 20 patients with superficial esophageal cancer, achieving a 100% detection rate with CTLG and 95% with IGFI.

This method not only successfully identified SLNs but also proved to be clinically applicable and less invasive, potentially improving the treatment process for superficial esophageal cancer while saving time and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy using intraoperative indocyanine green fluorescence imaging navigated with preoperative CT lymphography for superficial esophageal cancer. Yuasa, Y., Seike, J., Yoshida, T., et al.[2022]

In a clinical trial involving 169 patients, the combination of indocyanine green (ICG) and blue dye for sentinel lymph node (SLN) mapping resulted in a detection rate of 96.9% and a significantly lower false-negative rate of 3.4%, compared to 84.9% detection and 11.1% false-negative rate with blue dye alone.

The study demonstrated that using ICG in combination with blue dye not only improved the accuracy of SLN detection but also enhanced the prediction of axillary lymph node status in breast cancer patients, making it a more effective method for surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Fluorescence Imaging in Combination with Patent Blue Dye versus Patent Blue Dye Alone in Sentinel Lymph Node Biopsy in Breast Cancer. Tong, M., Guo, W., Gao, W.[2021]

In a study involving 50 patients with early breast cancer, the combination of indocyanine green (ICG) and blue dye for sentinel lymph node (SLN) localization achieved a high nodal detection rate of 100% for ICG alone and 96% when combined with blue dye, demonstrating the efficacy of ICG in SLN biopsy.

The use of ICG fluorescence imaging is not only sensitive and safe but also offers a potential alternative to radioisotope tracers, improving patient convenience and reducing costs in SLN detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence mapping for sentinel lymph node biopsy in early breast cancer. Pitsinis, V., Provenzano, E., Kaklamanis, L., et al.[2022]

The study successfully developed three types of anionic pullulan nanoparticles (NPs) with sizes under 50 nm, which can effectively load indocyanine green (ICG) and potentially improve its stability and reduce toxicity for sentinel lymph node (SLN) imaging.

Among the nanoparticles, CHPC2 showed the highest negative surface charge, which may enhance its effectiveness in SLN applications, while also demonstrating low toxicity to normal cells, indicating a safer option for medical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro Function Study of Different Negative Charge Pullulan Nanoparticles for Sentinel Lymph Node Angiography. Huang, RF., Guo, Y., Yao, C., et al.[2023]

Indocyanine green (ICG) demonstrated a sensitivity of 87% for detecting sentinel lymph nodes, making it more effective than blue dye, which had a sensitivity of only 44%.

ICG is a safe and effective alternative to blue dye in sentinel lymph node biopsies, potentially reducing the need for lymphoscintigraphy and minimizing anesthesia time for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescent-guided surgery and the use of indocyanine green sentinel lymph node mapping in the pediatric and young adult oncology population. Johnston, ME., Farooqui, ZA., Nagarajan, R., et al.[2023]

Indocyanine green (ICG) fluorescence imaging demonstrated a high sensitivity of 100% for sentinel lymph node (SLN) detection in early breast cancer, confirming its effectiveness when used alongside blue dye and radiocolloid.

The combination of ICG and blue dye provided the highest detection rate at 95%, suggesting a dual approach that could eliminate the need for radioisotope in SLN biopsies, enhancing safety and simplifying the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study (ICG-10) of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer. Wishart, GC., Loh, SW., Jones, L., et al.[2022]

In a study of 21 patients with esophageal squamous cell carcinoma (ESCC), near-infrared (NIR) imaging successfully identified sentinel lymph nodes during minimally invasive esophagectomy, achieving a high detection rate of 95.2%.

The method demonstrated excellent accuracy and negative predictive value for early-stage (pT1/T2) diseases, suggesting that NIR imaging-guided sentinel lymph node mapping is a promising and less invasive approach for detecting lymph node metastases in ESCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-Infrared Fluorescent Image-Guided Lymphatic Mapping in Esophageal Squamous Cell Carcinoma. Jiang, H., Teng, H., Sun, Y., et al.[2022]

In a study of 77 patients with early-stage gastric cancer, indocyanine green (ICG) fluorescence imaging demonstrated a high detection rate (94.7%) for sentinel nodes during laparoscopic surgery, comparable to conventional open surgery (94.9%).

The use of ICG fluorescence imaging for sentinel node mapping showed high accuracy (97.2%) and a relatively low false-negative rate (25%) in laparoscopic procedures, suggesting it is a promising method for predicting lymph node metastasis in gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node mapping guided by indocyanine green fluorescence imaging during laparoscopic surgery in gastric cancer. Tajima, Y., Murakami, M., Yamazaki, K., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Macrophage-Targeted Indocyanine Green-Neomannosyl Human Serum Albumin for Intraoperative Sentinel Lymph Node Mapping in Porcine Esophagus. [2022]

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

Performance of Indocyanine-Green Imaging for Sentinel Lymph Node Mapping and Lymph Node Metastasis in Esophageal Cancer: Systematic Review and Meta-Analysis. [2021]

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

Laparoscopic Typical and Atypical Locations of Sentinel Node Mapping with Indocyanine Green: Comparison of 2 Near-Infrared Fluorescence Systems. [2019]

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

Sentinel lymph node biopsy using intraoperative indocyanine green fluorescence imaging navigated with preoperative CT lymphography for superficial esophageal cancer. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Use of Fluorescence Imaging in Combination with Patent Blue Dye versus Patent Blue Dye Alone in Sentinel Lymph Node Biopsy in Breast Cancer. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence mapping for sentinel lymph node biopsy in early breast cancer. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

In vitro Function Study of Different Negative Charge Pullulan Nanoparticles for Sentinel Lymph Node Angiography. [2023]

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

Fluorescent-guided surgery and the use of indocyanine green sentinel lymph node mapping in the pediatric and young adult oncology population. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A feasibility study (ICG-10) of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer. [2022]

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

Near-Infrared Fluorescent Image-Guided Lymphatic Mapping in Esophageal Squamous Cell Carcinoma. [2022]

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

Sentinel node mapping guided by indocyanine green fluorescence imaging during laparoscopic surgery in gastric cancer. [2022]