SLN Mapping and ICG Dye for Vulvar Cancer

September 23, 2025 updated by: Tufts Medical Center

Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)

Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
        • Principal Investigator:
          • Katina Robison, MD
        • Contact:
        • Principal Investigator:
          • Rafael Gonzalez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

10 participants fitting the above criteria at Tufts Medical Center

Description

Inclusion Criteria:

  • 18 years of age or older
  • Patients with early-stage SCC (diameter <4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.
  • Patients with squamous cell carcinoma, depth of invasion > 1mm
  • Patients with T1 or T2 tumors (FIGO staging) < 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes
  • Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
  • Preoperative imaging do not show enlarged (<1.5 cm)/ suspicious nodes
  • Willing and able to give informed consent

Exclusion Criteria:

  • Inoperable tumors and tumors with diameter > 4 cm
  • Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
  • Radiologically enlarged (>1.5 cm) inguinofemoral lymph nodes
  • Patients with multifocal tumors
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Combined ICG dye and blue tracer dye
This study is being done to see if a different way of finding and removing lymph nodes during surgery, using a special camera and a dye called Indocyanine Green (ICG), works as well as the usual method with blue dye plus a radioactive tracer called radiocolloid. By comparing the two ways directly, we hope to make it simpler for people with vulvar cancer to get their lymph nodes checked during surgery.
Drug: Indocyanine green
Indocyanine green (ICG) is a fluorescent dye that has been used for the imaging of cancers in the body for more than 30 years.
Other Names:
  • ICG dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level
Time Frame: Data collection at time of surgery
  • Report the detection rate of SLNs using ICG dye for sentinel lymph node mapping.
  • Report the detection rate of SLNs using blue dye for sentinel lymph node mapping.
  • Compare the two detection rates using a chi-squared test or Fisher's exact test, depending on the sample size.
Data collection at time of surgery
Clustered Analysis at the Hemi-Pelvis Level
Time Frame: Data collection at time of surgery
  • Use generalized estimating equations (GEE) or mixed-effects logistic regression models to account for the clustering effect.
  • Include a random effect for each patient to address the correlation between SLNs within the same patient's hemi-pelvis.
  • Assess the significance of dye type using the Wald test or likelihood ratio test.
  • Report odds ratios, confidence intervals, and p-values for the effect of dye type on SLN detection.
Data collection at time of surgery
3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level
Time Frame: Data collection at time of surgery
  • Report the proportion of SLNs detected using blue dye in each hemi-pelvis.
  • Report the proportion of SLNs detected using ICG dye in each hemi-pelvis.
  • Use a paired t-test or Mcnemar's test to compare the proportions within each hemi-pelvis.
  • Account for the clustering effect by using mixed-effects models
Data collection at time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye
Time Frame: Data collection at time of surgery
  • Create a 2x2 contingency table for sensitivity, specificity, and negative predictive value.
  • Sensitivity = (True Positives) / (True Positives + False Negatives).
  • Specificity = (True Negatives) / (True Negatives + False Positives).
  • Negative Predictive Value = (True Negatives) / (True Negatives + False Negatives).
Data collection at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Rafael Gonzalez, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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