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

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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

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.
    


Study Type

Interventional


Primary Outcome

Progression-free survival

Secondary Outcome

 Overall Survival

Condition

Vulvar Cancer

Intervention

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

Study Arms / Comparison Groups

 Patients FIGO IB stage
Description:  Vulvar Cancer IB stage

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

2

Start Date

July 9, 2020

Completion Date

July 20, 2023

Primary Completion Date

July 20, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage

        Exclusion Criteria:

        -
      

Gender

Female

Ages

20 Years - 100 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Paolo Scollo, Prof., 0957262273, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04663412

Organization ID

8337


Responsible Party

Principal Investigator

Study Sponsor

Azienda Ospedaliera per l'Emergenza Canizzaro


Study Sponsor

Paolo Scollo, Prof., Principal Investigator, A.O.E. Cannizzaro


Verification Date

December 2020