Health TrialsbyHealthPanel

SLN Mapping and ICG Dye for Vulvar Cancer

ConditionVulva Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTufts Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

10 participants fitting the above criteria at Tufts Medical Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Combined ICG dye and blue tracer dye1 intervention

Trial outcomes

Primary outcomes

1

Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level

* 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.

Time frame
Data collection at time of surgery
2

Clustered Analysis at the Hemi-Pelvis Level

* 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.

Time frame
Data collection at time of surgery
3

3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level

* 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

Time frame
Data collection at time of surgery

Secondary outcomes

1

Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye

* 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).

Time frame
Data collection at time of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: