Mapping lymph nodes in esophageal cancer using special dye and imaging
Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer
This study is testing if using a special dye and imaging can help surgeons find and remove only the important lymph nodes in patients with esophageal cancer, making surgery less extensive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04400292 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the effectiveness of sentinel lymph node (SLN) mapping using indocyanine green (ICG) dye and near-infrared (NIR) imaging in patients with esophageal or esophagogastric junction cancer. By identifying sentinel lymph nodes, surgeons may be able to remove only these nodes instead of all lymph nodes during surgery, potentially reducing the extent of surgery required. The study focuses on patients diagnosed with adenocarcinoma in the distal esophagus or esophagogastric junction who are scheduled for minimally invasive esophagectomy. The approach involves injecting ICG dye and utilizing NIR imaging to visualize the lymphatic drainage during the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates include adults with a pathological diagnosis of adenocarcinoma located in the distal esophagus or esophagogastric junction who are planning to undergo minimally invasive esophagectomy.
Not a fit: Patients who are not planning to undergo surgical resection or have advanced Stage IVB or M1 disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to less invasive surgeries and improved recovery for patients with esophageal cancer.
How similar studies have performed: Other studies have shown promise in using similar techniques for lymph node mapping, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy. * All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be eligible * ≥18 years of age. * Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection. Exclusion Criteria: * No plan to undergo surgical resection. * Severe iodide or seafood allergy. * Women of childbearing potential without a negative pregnancy test; or women who are lactating. * Prior diagnosis of severe hepatic or renal dysfunction. * Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition) * Patients with local recurrence and planning to undergo salvage esophagectomy
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniela Molena, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Daniela Molena, MD
- Email: molenad@mskcc.org
- Phone: 212-639-3870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.