SLN Mapping and ICG Dye for Vulvar Cancer

NCT ID: NCT06035068

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Indocyanine green

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ICG dye

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Rafael Gonzalez, MD

Role: CONTACT

rafael.gonzalez@tuftsmedicine.org

617-636-6058

Katina Robison, MD

Role: CONTACT

katina.robison@tuftsmedicine.org

Facility Contacts

Alysa St. Charles, MA

Role: primary

alysa.st.charles@tuftsmedicine.org

617-636-9897

References

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.

Reference Type: BACKGROUND

PMID: 26428940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25703673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21963099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21056907 (View on PubMed)

Other Identifiers

STUDY00004163

Identifier Type: -

Identifier Source: org_study_id