- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663412
Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer
Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer: Peritumoral Injection Dosage and Waiting Times in Our Experience
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paolo Scollo, Prof.
- Phone Number: 0957262273
- Email: paolo@scollo.org
Study Contact Backup
- Name: Martina Ferrara, Dr.
- Email: martiferra@hotmail.it
Study Locations
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Catania, Italy, 95126
- Recruiting
- Ginecologia e Ostetricia
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Contact:
- Paolo Scollo, Prof
- Phone Number: 0957262273
- Email: paolo@scollo.org
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Contact:
- Martina Ferrara, Dr
- Email: martiferra@hotmail.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients FIGO IB stage
Vulvar Cancer IB stage
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 3 years
|
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.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 3 years
|
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.
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3 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Paolo Scollo, Prof., A.O.E. Cannizzaro
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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