A diagnostic sensitivity study comparing intradermal indocyanine green (ICG) and near infrared fluorescence imaging (NIRFI) with intradermal technetium 99m and traditional lymphoscintigraphy (LS) for transcutaneous identification of sentinel lymph nodes (SLN) in malignant melanoma – a prospective Phase II clinical study in a single center.
Full Title of Study: “A Diagnostic Sensitivity Study Comparing Intradermal ICG and NIRFI With Intradermal Technetium 99m and Traditional Lymphoscintigraphy for Transcutaneous Identification of Sentinel Lymph Nodes in Malignant Melanoma”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: June 30, 2020
Switzerland has the highest rate of new melanomas in Europe (19.2 per 100,000). Melanomas have the worst prognosis of all skin cancers. The current treatment depends on the histological diagnosis after a biopsy and is primarily related to the tumor thickness (Breslow Score), the tumor cells in division (mitosis rate), the substance defect of the skin (ulceration), the occurrence of regression, and the age of the patients. The initial treatment is performed by surgical removal with a safety margin of macroscopically healthy skin around the tumor. If the tumor thickness is more than 1 mm or more than 0.7 mm associated with a high mitosis rate in younger patients, ulcerations, regression or Clark Level IV / V, then current melanoma guidelines suggest that the patient undergoes sentinel lymph node biopsy (SLKB) as this is most likely the first site where metastases spread. Merkel cell carcinoma is a very aggressive, neuroendocrine skin tumor with a mortality rate of about 33% after 3 years. Due to the frequent lymphatic metastases, SLNB is highly recommended in all patients in order to better assess their prognosis. The gold standard technique to identify SLKs is to inject the radioisotope Technetium-99m around the primary tumor into the skin. The patient is then scanned to determine the position of the SLK after approximately 30 and 120 minutes. Other teams have attempted to identify transcutaneous SLK with ICG and NIRFI, but have concluded that ICG fluorescence technique is not reliable in patients with high BMI or a primary tumor with lymph drainage in the axillary lymph node region. This study aims to evaluate a medical device that uses an improved technology compared to previous studies (stereoscopic 3D high definition for both fluorescence and visible light imaging). The investigators hope is that by applying similar principles SLKs can be identified through the use of transcutaneous fluorescent dye injections and NIRFI.
- Diagnostic Test: Visionsense™ VS3 – Stereoscopic High Definition Visualisation System (VS3-3DHD)
- Injection of ICG intradermally around the scar of the primary excision of the tumour and transcutaneous assessment of fluorescence with the VS3-3DHD camera (Visionsense™ VS3 – Stereoscopic High Definition Visualisation System ).
Arms, Groups and Cohorts
- Experimental: Comparison result lymphoscintigraphy with ICG lymphography
- The patient first receives a standard Tc-99m-based lymphoscintigraphy. The identified lymph nodes are not marked in the patients, so that the surgeons are not affected in lymph node identification during ICG and near infrared fluorescence imaging. The surgeon also has no access to lymphoscintigraphy images. Transcutaneous ICG lymphography is then performed by intradermal injection of ICG around the scar of the primary tumor excision and transcutaneous fluorescence evaluation with the Visionsense™ VS3 – Stereoscopic High Definition Visualisation System (VS3-3DHD) and results are compared.
Clinical Trial Outcome Measures
- Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.
- Time Frame: one hour
- To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS.
- Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging in specific anatomical locations and in defined patient groups (e.g. groups defined based on BMI, sex, age).
- Time Frame: one hour
- The study seeks primarily to determine ability of the VisionSense NIRFI technology to transcutaneously identify SLNs as effectively as LS.
Participating in This Clinical Trial
- Malignant melanoma patients having one of the following characteristics:
- Breslow score ≥ 1 mm
- Breslow score ≥ 0.7 mm associated with ulceration
- Breslow score ≥ 0.7 mm associated with regression
- Breslow score ≥ 0.7 mm associated with Clark Level IV / V
- Breslow score ≥ 0.7 mm associated with mitotic rate ≥ 1/mm2 in young patients
- Merkel cell carcinoma
- Age < 18 years
- Pregnancy and breastfeeding (pregnancy test to be performed for women of child-bearing potential, defined as women who are not surgically sterilized/ hysterectomized, and/or who are postmenopausal for less than 12 months)
- Known allergy to ICG or Iodine
- Previous chemotherapy, radiotherapy or surgery to the lymph nodes of interest
- Lack of capacity to provide informed consent
- Current enrolment in any other interventional study
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University Hospital Inselspital, Berne
- Provider of Information About this Clinical Study
- Overall Official(s)
- Mihai A. Constantinescu, Professor, Study Director, Director of Clinic for Plastic and Reconstructive Surgery, Inselspital Bern, Switzerland
- Radu Olariu, MD, Principal Investigator, Deputy chief physician of Clinic for Plastic and Reconstructive Surgery, Inselspital Bern, Switzerland
- Overall Contact(s)
- Radu Olariu, MD, +41316328014, firstname.lastname@example.org
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