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SLN Mapping with ICG + NIR Imaging for Esophageal Cancer

N/A
Recruiting
Led By Daniela Molena, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction, with a plan to undergo minimally invasive esophagectomy
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a new method of identifying cancerous lymph nodes is effective in patients with esophageal or esophagogastric junction cancer. If successful, surgeons in the future could remove only the cancerous lymph nodes instead of all of them.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the ICG dye, which could be similar to seafood allergy symptoms since ICG contains iodine. Other risks involve typical surgical complications from sentinel node mapping procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am 18 years old or older.
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My cancer is at Stage IVA according to the AJCC 8th edition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of lymph nodes visualized to be fluorescent and nonfluorescent.

Trial Design

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 Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,750 Total Patients Enrolled
Daniela Molena, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
4,080 Total Patients Enrolled

Media Library

Sentinel Lymph Node (SLN) mapping Clinical Trial Eligibility Overview. Trial Name: NCT04400292 — N/A
Esophageal Cancer Research Study Groups: SLN mapping by NIR with ICG
Esophageal Cancer Clinical Trial 2023: Sentinel Lymph Node (SLN) mapping Highlights & Side Effects. Trial Name: NCT04400292 — N/A
Sentinel Lymph Node (SLN) mapping 2023 Treatment Timeline for Medical Study. Trial Name: NCT04400292 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target participant pool size for this clinical trial?

"Affirmative, clinicaltrials.gov's records indicate that this medical research is recruiting participants currently. The trial was first posted on May 20th 2020 and has been updated most recently on September 30th 2022. 60 individuals are being sought from one site for the study."

Answered by AI

Are there remaining vacancies for patients in this study?

"The facts posted on clinicaltrials.gov imply that this study is still searching for new volunteers, having been uploaded to the platform in May 2020 and updated most recently at the end of September 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging
2020. "Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04400292.
All > Esophagus Cancer > Esophageal Cancer
~12 spots leftby May 2025
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