NCT06127836

Brief Summary

The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer. The researchers will compare indocyanine green near-infrared (ICG-NIR) imaging with lymphoscintigraphy. All participants in this study will be scheduled for standard surgical treatment at Memorial Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2023Nov 2026

Study Start

First participant enrolled

November 6, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

November 7, 2023

Last Update Submit

November 4, 2025

Conditions

Vulvar Cancer

Keywords

Near-Infrared ImagingIndocyanine GreenSentinel Lymph Nodes23-310

Outcome Measures

Primary Outcomes (1)

  • success of identifying the SLN

    by use of near-infrared imaging with ICG injection. Patients will be eligible for assessment if they undergo attempted SLN mapping by lymphoscintigraphy and near-infrared imaging with ICG injection. The primary endpoint is the accurate identification of the SLN, defined as the uptake of ICG in the proximalmost draining lymph node in the inguinofemoral chain. Evaluate the ability of near-infrared imaging with ICG injection to detect the inguinofemoral SLN in patients with early-stage vulvar cancer, compared with radiocolloid lymphoscintigraphy, the current standard.

    18 months

Study Arms (1)

patients undergoing preoperative lymphoscintigraphy

EXPERIMENTAL

Patients will undergo radiocolloid lymphoscintigraphy before their surgery; the surgeon will be blinded to the results of this procedure. The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only.

Procedure: ICG guided sentinel lymph node biopsy

Interventions

ICG guided sentinel lymph node biopsyPROCEDURE

The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only. Once the surgeon has identified the SLN in this way, he or she will be unblinded to the results of the lymphoscintigraphy and will use the results of preoperative imaging and an intraoperative gamma counter to confirm the SLNs.

patients undergoing preoperative lymphoscintigraphy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsVulvar cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years of age
  • Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients with squamous cell carcinomas and melanomas will be included)
  • Primary tumor ≤4 cm in size
  • For patients with squamous cell carcinoma, \>1 mm of invasion is required

You may not qualify if:

  • Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is performed)
  • Presence of distant metastases
  • Absolute contraindication to radiocolloid Tc-99 or ICG
  • Nonsquamous or nonmelanoma histologic subtype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Houston Methodist Cancer Center (Data Collection Only)

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Vance Broach, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Surgeons will be blinded to the results of the lymphoscintigraphy and will perform SLN biopsy in the operating room using near-infrared imaging with ICG injection. And the results will not be released until the consenting surgeon contacts the Nuclear Medicine team after attempting to identify the SLN by use of near-infrared imaging with ICG injection.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: This is a prospective study to evaluate the performance of near-infrared imaging with ICG injection, compared with lymphoscintigraphy, for the detection of the inguinofemoral SLN in patients with vulvar cancer.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

November 6, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(8)