SLN Mapping with ICG + NIR Imaging for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Severe allergy, Pregnancy, Hepatic dysfunction, others
No Placebo Group
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.
12345Is 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.
36789How 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.
2361011Eligibility 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 am 18 years old or older.
I have signed the consent forms for both the study and surgery.
+1 more
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.
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: SLN mapping by NIR with ICGExperimental Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, NY
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Macrophage-Targeted Indocyanine Green-Neomannosyl Human Serum Albumin for Intraoperative Sentinel Lymph Node Mapping in Porcine Esophagus. [2022]The sentinel lymph node (SLN) concept has been proposed to avoid unnecessary invasive LN dissection in surgery for esophageal cancer. This study evaluated a new macrophage-targeting fluorescent agent, indocyanine green-neomannosyl human serum albumin (ICG:MSA), for SLN mapping using a custom-made intraoperative color and fluorescence-merged imaging system (ICFIS) in porcine esophagus.
Performance of Indocyanine-Green Imaging for Sentinel Lymph Node Mapping and Lymph Node Metastasis in Esophageal Cancer: Systematic Review and Meta-Analysis. [2021]Lymphatic mapping with indocyanine-green (ICG) and near-infrared light fluorescent imaging is widely used for sentinel lymph node staging in different types of cancer but is not fully accepted for all procedures because studies have reported heterogeneous results. This study aimed to assess the detection rate (DR) of ICG imaging for sentinel lymph node mapping (SLNM) and lymph node metastases (LNMs) in esophageal cancer.
Laparoscopic Typical and Atypical Locations of Sentinel Node Mapping with Indocyanine Green: Comparison of 2 Near-Infrared Fluorescence Systems. [2019]To present our minimally invasive laparoscopic approach for sentinel lymph node (SLN) mapping with indocyanine green (ICG) using 2 fluorescence systems.
Sentinel lymph node biopsy using intraoperative indocyanine green fluorescence imaging navigated with preoperative CT lymphography for superficial esophageal cancer. [2022]The sentinel lymph node (SLN) concept has been gaining attention for gastrointestinal neoplasms but remains controversial for esophageal cancer. This study evaluated the feasibility of SLN identification using intraoperative indocyanine green (ICG) fluorescence imaging (IGFI) navigated by preoperative computed tomographic lymphography (CTLG) to treat superficial esophageal cancer.
Use of Fluorescence Imaging in Combination with Patent Blue Dye versus Patent Blue Dye Alone in Sentinel Lymph Node Biopsy in Breast Cancer. [2021]Near-infrared fluorescence imaging with indocyanine green (ICG) has the potential to improve sentinel lymph node (SLN) mapping in breast cancer. In this clinical trial, we compared the potential value of ICG combined with blue dye with that of blue dye alone for detecting SLNs.
Indocyanine green fluorescence mapping for sentinel lymph node biopsy in early breast cancer. [2022]A recent feasibility study (ICG-10) has confirmed high sensitivity of ICG fluorescence mapping for sentinel SLN detection in early breast cancer with 95% of nodes both blue and fluorescent. This follow-on study has specifically evaluated a combination of ICG and blue dye for SLN localization.
In vitro Function Study of Different Negative Charge Pullulan Nanoparticles for Sentinel Lymph Node Angiography. [2023]Many dyes or radioactive markers used for sentinel lymph node (SLN) have the shortcomings of false positive and radiation injury. Indocyanine green (ICG) seems to have a lower false positive rate and tissue damage, without a clear field of vision during the operation.
Fluorescent-guided surgery and the use of indocyanine green sentinel lymph node mapping in the pediatric and young adult oncology population. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Technetium-99 (99m Tc) lymphoscintigraphy with blue dye injection is an accepted method for sentinel lymph node (SLN) mapping, but blue dye has known adverse effects, and injection of 99m Tc may increase time under anesthesia for pediatric patients. Indocyanine green (ICG) may serve as an adjunct to assist with visibility and identification of SLNs. We hypothesized that sensitivity of ICG was similar to blue dye in SLN biopsies.
A feasibility study (ICG-10) of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer. [2022]There is now increasing evidence to support the use of indocyanine green (ICG) for sentinel lymph node (SLN) detection in early breast cancer. The primary objective of this feasibility study (ICG-10) was to determine the sensitivity and safety of ICG fluorescence imaging in sentinel lymph node identification when combined with blue dye and radiocolloid.
Near-Infrared Fluorescent Image-Guided Lymphatic Mapping in Esophageal Squamous Cell Carcinoma. [2022]Recently, the feasibility of near-infrared (NIR) image-guided sentinel lymph node (SLN) mapping has been tested in patients with gastrointestinal cancer. The aim of this study is to investigate whether SLN mapping can be used to identify mediastinal lymph node metastases during minimally invasive esophagectomy and explore the lymphatic drainage pattern of esophageal squamous cell carcinoma (ESCC) using NIR fluorescent imaging.
Sentinel node mapping guided by indocyanine green fluorescence imaging during laparoscopic surgery in gastric cancer. [2022]Indocyanine green (ICG) fluorescence imaging has recently been reported as a new method for sentinel node (SN) mapping in several types of cancers. In this study, we determined the possible usefulness of SN mapping guided by ICG fluorescence imaging during laparoscopy-assisted gastrectomy (LAG) for gastric cancer.