search
Back to results

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

Primary Purpose

Vulvar Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sentinel lymph node mapping with indocyanine green fluorescence imaging in vulvar cancer (FIGO Stage IB)
Sponsored by
Azienda Ospedaliera per l'Emergenza Canizzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vulvar Cancer focused on measuring vulvar cancer, indocyanine green, sentinel node, surgery, single center

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage

Exclusion Criteria:

-

Sites / Locations

  • Ginecologia e OstetriciaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients FIGO IB stage

Arm Description

Vulvar Cancer IB stage

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
The length of time from either the date of diagnosis or the start of treatment for vulvar cancer, that patients diagnosed with the disease are still alive.

Full Information

First Posted
December 1, 2020
Last Updated
December 6, 2020
Sponsor
Azienda Ospedaliera per l'Emergenza Canizzaro
search

1. Study Identification

Unique Protocol Identification Number
NCT04663412
Brief Title
Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer
Official Title
Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer: Peritumoral Injection Dosage and Waiting Times in Our Experience
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera per l'Emergenza Canizzaro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
According to The European Society of Gynaecological Oncology (ESGO) guidelines, the investigators decided to treat patients with vulvar squamous cell carcinoma (vSCC), FIGO stage IB with radical vulvectomy, sentinel lymph node search, and removal with indocyanine green (ICG) subsequent bilateral inguinofemoral lymphadenectomy. Intraoperative imaging system The SPY Portable Handheld Imager (SPY-PHI) © Stryker was used as the intraoperative imaging device. This device uses SPY fluorescence imaging technology to visually assess blood circulation in blood vessels and associated tissue perfusion during surgery. The design of SPY-PHI makes the device versatile, enabling the operator to frame the operating field and use the acquired images in real-time, integrating fluorescence signal data with white light images in real-time. The SPY Portable Handheld Imaging System Camera, with integrated optics and cables for real-time fluorescence imaging in visible light and near-infrared, is ideal for open surgery. Intraoperative detection of the sentinel lymph node The fluorescent agent was administered to patients placed in the lithotomy position under general anesthesia. Indocyanine green (ICG) prepared with a 25 mg vial of green indocyanine green (ICG) (Pulsion Medical Systems AG, Munich, Germany) diluted in 50 mL of water for injections (B. Braun Medical) was used, resulting in a concentration of 0.5 mg/mL. Injection of 1 ml per quadrant was administered in the three quadrants around the vulvar lesion. After the injection, the infrared camera, equipped with a movable arm, was placed in front of the patient to detect transcutaneous fluorescence during surgery. Subsequently, the SLN was localized based on the fluorescence intensity. The intraoperative fluorescence detection camera system was used to open, identify, and remove the SLN and the vulvectomy of the groin. After the excision, the capture of the residual lymphatic pathway could be seen bilaterally through the infrared camera. Additionally, all SLNs were subject to ex vivo imaging due to the presence of fluorescence. The excised SLNs were sent to pathological anatomy and processed according to the standard SLN protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
vulvar cancer, indocyanine green, sentinel node, surgery, single center

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients FIGO IB stage
Arm Type
Experimental
Arm Description
Vulvar Cancer IB stage
Intervention Type
Other
Intervention Name(s)
Sentinel lymph node mapping with indocyanine green fluorescence imaging in vulvar cancer (FIGO Stage IB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The length of time from either the date of diagnosis or the start of treatment for vulvar cancer, that patients diagnosed with the disease are still alive.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Scollo, Prof.
Phone
0957262273
Email
paolo@scollo.org
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Ferrara, Dr.
Email
martiferra@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Scollo, Prof.
Organizational Affiliation
A.O.E. Cannizzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ginecologia e Ostetricia
City
Catania
ZIP/Postal Code
95126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Scollo, Prof
Phone
0957262273
Email
paolo@scollo.org
First Name & Middle Initial & Last Name & Degree
Martina Ferrara, Dr
Email
martiferra@hotmail.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs