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Observational Study of Indocyanine Green (ICG) Dye for Vulvar Cancer

This study is looking at a different way to find lymph nodes in women with early-stage vulvar cancer. Doctors usually use a blue dye to help find these lymph nodes during surgery. This study compares that standard blue dye method with a new method using Indocyanine green (ICG) dye. ICG is a special dye that glows when a camera shines light on it, which might make it easier to find lymph nodes. The study wants to see how well ICG dye helps doctors find these lymph nodes compared to the blue dye. You may be able to join if you are 18 or older, have early-stage squamous cell carcinoma (SCC) of the vulva, and are scheduled for surgery at Tufts Medical Center. The study aims to enroll 10 participants.

Study design
This is an observational study comparing two methods for finding lymph nodes during surgery. It plans to include 10 participants.
What's involved
Data will be collected at the time of your surgery.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at the time of surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06035068

SLN Mapping and ICG Dye for Vulvar Cancer

Not Yet Recruiting
Not specifiedAges 18+Observational
Tufts Medical Center
~10 participants
Updated 2025-09-29 on ClinicalTrials.gov
What's tested:Indocyanine green

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level
Measured over Data collection at time of surgery
+2 more outcomes measured

Conditions

Vulva Cancer

Explore related trials

Vulvar Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Rafael Gonzalez, MD · PRINCIPAL_INVESTIGATOR · Tufts Medical Center

Who to contact

Rafael Gonzalez, MD
[email protected]
617-636-6058
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient LevelData 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.

  • Clustered Analysis at the Hemi-Pelvis LevelData 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. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis LevelData 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