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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Vulvar Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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patients undergoing preoperative lymphoscintigraphy

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.

Group Type EXPERIMENTAL

ICG guided sentinel lymph node biopsy

Intervention Type 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. 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.

Interventions

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ICG guided sentinel lymph node biopsy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ≥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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No