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NCT Number: NCT06035068

SLN Mapping and ICG Dye for Vulvar Cancer

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.

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Key information

Conditions

Vulva Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location contact

Alysa St. Charles, MA

CONTACT

[email protected]

617-636-9897

Katina Robison, MD

PRINCIPAL_INVESTIGATOR

Rafael Gonzalez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Katina Robison, MD

CONTACT

[email protected]

Rafael Gonzalez, MD

CONTACT

[email protected]

617-636-6058

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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