ACTIVE_NOT_RECRUITING

Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer

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Conditions

Vulvar CancerNear-Infrared ImagingIndocyanine GreenSentinel Lymph Nodes23-310

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

VISION (Vulvar ICG SLN Detection) Study: Near-Infrared Imaging With Indocyanine Green Injection for the Detection of Sentinel Lymph Nodes in Vulvar Cancer

Quick Facts

Study Start:2023-11-06
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06127836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients with squamous cell carcinomas and melanomas will be included)
  3. * Primary tumor ≤4 cm in size
  4. * For patients with squamous cell carcinoma, \>1 mm of invasion is required
  1. * Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is performed)
  2. * Presence of distant metastases
  3. * Absolute contraindication to radiocolloid Tc-99 or ICG
  4. * Nonsquamous or nonmelanoma histologic subtype

Contacts and Locations

Principal Investigator

Vance Broach, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States
Houston Methodist Cancer Center (Data Collection Only)
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Vance Broach, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-06
Study Completion Date2026-11

Study Record Updates

Study Start Date2023-11-06
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Near-Infrared Imaging
  • Indocyanine Green
  • Sentinel Lymph Nodes
  • 23-310

Additional Relevant MeSH Terms

  • Vulvar Cancer