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Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer

NCT04663412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-12-11

No results posted yet for this study

Summary

The potential of the administration of indocyanine green (ICG) allows the execution of SLN biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase, painful for the patient, elimination, and exposure to radioactivity. Therefore, while requiring standardization of the methodology and a large-scale application, this procedure could open a new surgical management perspective in patients with early-stage vulvar cancer.

Conditions

  • Vulvar Cancer

Interventions

OTHER

Sentinel lymph node mapping with indocyanine green fluorescence imaging in vulvar cancer (FIGO Stage IB)

Patients diagnosed with vulvar squamous cell carcinoma (FIGO IB stage) underwent bilateral radical vulvectomy, SLN search and removal, and bilateral inguinal lymphadenectomy at the Cannizzaro Hospital Operative Unit of Obstetrics and Gynecology Department (Catania, Italy). 3 ml of indocyanine green (ICG) 0.5 mg/mL was administered in 3 peritumoral injections under general anesthesia to screen the SLN. The images were acquired using an intraoperative infrared camera system, which allowed intraoperative visualization of the SLN. An SLN was identified for each patient. The lymph nodes examined by the pathologist were negative for metastatic localization of the disease. However, patients underwent bilateral inguinofemoral lymphadenectomy, as this procedure is not currently codified as a gold standard for the detection of SLN in vulvar cancer.

Sponsors & Collaborators

  • Azienda Ospedaliera per l'Emergenza Canizzaro

    lead OTHER

Principal Investigators

  • Paolo Scollo, Prof. · A.O.E. Cannizzaro

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2021-07-20
Completion
2023-07-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04663412 on ClinicalTrials.gov