SLN Mapping and ICG Dye for Vulvar Cancer

NCT06035068 | Not Yet Recruiting FDA Drug

• 1 other identifier: STUDY00004163
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulva Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  Data collection at time of surgery

• 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.

  Data collection at time of surgery

• 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

  Data collection at time of surgery

Secondary Outcomes (1)

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

  Data collection at time of surgery

Study Arms (1)

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

Interventions

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.

Also known as: ICG dye

Combined ICG dye and blue tracer dye

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

10 participants fitting the above criteria at Tufts Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• Te Grootenhuis NC, van der Zee AG, van Doorn HC, van der Velden J, Vergote I, Zanagnolo V, Baldwin PJ, Gaarenstroom KN, van Dorst EB, Trum JW, Slangen BF, Runnebaum IB, Tamussino K, Hermans RH, Provencher DM, de Bock GH, de Hullu JA, Oonk MH. Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I. Gynecol Oncol. 2016 Jan;140(1):8-14. doi: 10.1016/j.ygyno.2015.09.077. Epub 2015 Sep 30.

  PMID: 26428940 BACKGROUND

• Covens A, Vella ET, Kennedy EB, Reade CJ, Jimenez W, Le T. Sentinel lymph node biopsy in vulvar cancer: Systematic review, meta-analysis and guideline recommendations. Gynecol Oncol. 2015 May;137(2):351-61. doi: 10.1016/j.ygyno.2015.02.014. Epub 2015 Feb 20.

  PMID: 25703673 BACKGROUND

• Hutteman M, van der Vorst JR, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol. 2012 Jan;206(1):89.e1-5. doi: 10.1016/j.ajog.2011.07.039. Epub 2011 Jul 30.

  PMID: 21963099 BACKGROUND

• Crane LM, Themelis G, Arts HJ, Buddingh KT, Brouwers AH, Ntziachristos V, van Dam GM, van der Zee AG. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol. 2011 Feb;120(2):291-5. doi: 10.1016/j.ygyno.2010.10.009. Epub 2010 Nov 6.

  PMID: 21056907 BACKGROUND

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rafael Gonzalez, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Gonzalez, MD

CONTACT

617-636-6058; rafael.gonzalez@tuftsmedicine.org

Katina Robison, MD

CONTACT

katina.robison@tuftsmedicine.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: November 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)