Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study

Malignant Melanoma Clinical Trial

— LIMIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545334
• Other study ID #: KEK-Nr. 2016-01746
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Merkel Cell
• Malignant Melanoma
• Melanoma
• Merkel Cell Carcinoma

Intervention

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 ).

Locations

Country	Name	City	State
Switzerland	Inselspital, University Hospital Bern, University of Bern	Bern	Kanton Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.	To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS.	one hour
Secondary	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).	The study seeks primarily to determine ability of the VisionSense NIRFI technology to transcutaneously identify SLNs as effectively as LS.	one hour