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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special dye and imaging technique, specifically the injection of indocyanine green (ICG) dye and near-infrared image-guided technology, can accurately identify cancer spread in individuals with esophageal or esophagogastric junction cancer. Doctors seek to determine if they can remove only the affected lymph nodes instead of all of them, which is the current practice. Suitable candidates have been diagnosed with adenocarcinoma, located in the lower esophagus or where the esophagus meets the stomach, and are planning to undergo a specific type of surgery. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance surgical outcomes.

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 SLN mapping technique is safe for esophageal cancer?

Research has shown that using a special dye called indocyanine green (ICG) with near-infrared (NIR) imaging to identify important lymph nodes in esophageal cancer is safe. Studies have demonstrated that this method is effective and easy for patients to handle. For instance, one study found that using ICG-NIR during surgery helps doctors identify lymph nodes that might have cancer. Another study confirmed that this technique is safe and effectively locates nearby lymph nodes when ICG is used.

In simpler terms, this method has been tested on people before and did not cause major side effects. It helps doctors see which lymph nodes might have cancer, potentially leading to less invasive surgeries in the future. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using indocyanine green (ICG) dye with near-infrared (NIR) imaging for esophageal cancer because it offers a new approach to mapping the lymph nodes. Unlike traditional methods that rely on visual inspection or blue dye, this technique uses a special dye that lights up under near-infrared light, potentially making it easier to spot and accurately target sentinel lymph nodes. This could lead to more precise surgeries, reducing the chance of missing cancerous nodes and improving outcomes for patients. This innovative method holds promise for enhancing surgical precision and could significantly change how esophageal cancer is treated in the future.

What evidence suggests that SLN mapping with ICG and NIR imaging is effective for esophageal cancer?

In this trial, participants will undergo Sentinel Lymph Node (SLN) mapping using a special dye called indocyanine green (ICG) with near-infrared (NIR) imaging. Studies have shown that this method can help identify important lymph nodes in esophageal cancer and accurately predict which nodes might contain cancer. This approach may allow doctors to remove only the affected nodes, rather than all of them, as is typically done. One study suggested that ICG and NIR imaging is a promising tool for detecting cancer spread in squamous cell carcinoma, a type of esophageal cancer. Overall, this technique could make surgery less invasive and more precise. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniela Molena, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869681/

Indocyanine green near-infrared imaging-guided lymph ... This study aimed to investigate the feasibility of using indocyanine green (ICG) near-infrared (NIR) imaging during lymphadenectomy for oesophageal cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04400292?term=Daniela%20Molena%2C%20MD&rank=3

Sentinel Lymph Node Mapping in Esophageal Cancer ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10615981/

Lymphatic flow mapping using near-infrared fluorescence ... Lymphatic flow mapping using near-infrared fluorescence imaging with indocyanine green helps to predict lymph node metastasis intraoperatively ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0039606023008000

Comparison of indocyanine green-near-infrared ... Indocyanine green–near-infrared might be an important and promising technique in predicting sentinel lymph nodes of esophageal squamous cell carcinoma.

5. link.springer.com link.springer.com/article/10.1007/s00464-025-11703-7

The use of indocyanine green and near-infrared ... This paper aims to systematically review the efficacy of ICG in the context of image-guided lymphadenectomy in oesophageal and gastric cancer resection.

6. jtcvs.org jtcvs.org/article/S0022-5223(16)30083-6/fulltext

Safety and feasibility of near-infrared image-guided ... NIR lymphatic mapping is safe and feasible in patients with esophageal cancer and can identify regional LNs when ICG:HSA is used.

7. jcvaonline.com jcvaonline.com/article/S1053-0770(23)00414-7/fulltext

Indocyanine Green in Thoracic and Esophageal Surgery Indocyanine green dye–NIR fluorescence has the potential to facilitate surgical planning, stage disease, and reduce postoperative complications.