Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer
1 other identifier
interventional
2
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2020
CompletedFirst Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2023
CompletedDecember 11, 2020
December 1, 2020
1 year
December 1, 2020
December 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
The length of time during and after the treatment of vulvar cancer with sentinel node, that a patient lives with the disease but it does not get worse.
3 years
Secondary Outcomes (1)
Overall Survival
3 years
Study Arms (1)
Patients FIGO IB stage
EXPERIMENTALVulvar Cancer IB stage
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ginecologia e Ostetricia
Catania, 95126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Scollo, Prof.
A.O.E. Cannizzaro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 11, 2020
Study Start
July 9, 2020
Primary Completion
July 20, 2021
Study Completion
July 20, 2023
Last Updated
December 11, 2020
Record last verified: 2020-12