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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

Must not have

Patients with local recurrence and planning to undergo salvage esophagectomy

Prior diagnosis of severe hepatic or renal dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had severe liver or kidney problems.

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

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I am not pregnant or breastfeeding.

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My cancer is at the most advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of lymph nodes visualized to be fluorescent and nonfluorescent.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met