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Procedure

ICG Sentinel Lymph Node Mapping for Vulvar Cancer

N/A

Recruiting

Led By Vance Broach, 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

≥18 years of age

Primary tumor ≤4 cm in size

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is studying two methods of mapping sentinel lymph nodes for early-stage vulvar cancer before surgery at MSK. Both imaging methods and biopsy of the found nodes will be done.

Who is the study for?

This trial is for adults over 18 with early-stage vulvar cancer, scheduled for sentinel lymph node biopsy at MSK. It includes those with tumors up to 4 cm and squamous cell carcinoma patients must have more than 1 mm of invasion.Check my eligibility

What is being tested?

The study compares two imaging techniques for mapping sentinel lymph nodes in vulvar cancer: indocyanine green near-infrared (ICG-NIR) imaging versus traditional lymphoscintigraphy, during standard surgical treatment.See study design

What are the potential side effects?

Potential side effects are not specified in the provided information but may include typical risks associated with diagnostic imaging agents like allergic reactions or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My primary tumor is 4 cm or smaller.

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My squamous cell carcinoma has invaded more than 1 mm deep.

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I have recently been diagnosed with vulvar cancer and will have a sentinel lymph node biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

success of identifying the SLN

Trial Design

1Treatment groups

Experimental Treatment

Group I: patients undergoing preoperative lymphoscintigraphyExperimental Treatment1 Intervention

Patients will undergo radiocolloid lymphoscintigraphy before their surgery; the surgeon will be blinded to the results of this procedure. The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,858 Total Patients Enrolled

Vance Broach, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

23 Total Patients Enrolled

Frequently Asked Questions

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

Are there remaining slots in this clinical trial for participants?

"Affirmative. The medical trial is recruiting according to the information hosted on clinicaltrials.gov, which was first made available November 6th 2023 and most recently updated 16 days later. 40 participants are necessary from 7 distinct sites."

Answered by AI

How many medical facilities are participating in the execution of this experiment?

"The 7 sites that are currently enrolling patients include Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale, and Memorial Sloan Kettering Westchester (Limited Protocol Activities), located in Harrison. Other locations also exist to help with the recruitment process."

Answered by AI

How many people are actively involved in this research endeavor?

"Affirmative. Clinicaltrials.gov presents evidence that this clinical test, which was initially advertised on November 6th 2023, is actively recruiting patients for enrollment. Forty individuals are planned to be admitted from 7 distinct medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer

2023. "Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06127836.