Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study (LIMIT)
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|ClinicalTrials.gov Identifier: NCT03545334|
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma of Skin Staging (Diagnosis) Merkel Cell Carcinoma||Diagnostic Test: VS3 - 3DHD camera||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A diagnostic sensitivity study to analyse the ability of intradermally administered indocyanine green (ICG) and near infrared fluorescence imaging (NIRFI) to transcutaneously identify sentinel lymph nodes (SLNs) in malignant melanoma and Merkel cell carcinoma - after intradermally administered injection of technetium 99m and traditional lymphoscintigraphy (LS)|
|Masking:||None (Open Label)|
|Masking Description:||The surgeons performing SLNB will be the blinded persons. The results of the lymphoscintigraphy will not be marked on the patient's skin as usual and no preoperative access to the images will be granted to the surgeons.|
|Official Title:||Lymph Node Identification in Skin Malignancy Using Indocyanine Green Transcutaneously (LIMIT) Study|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: ICG and VS3-3DHD camera
After induction of anaesthesia, standard procedures for injection of a single dose Indocyanine green (ICG) intradermally are performed according to product description and hospital SOPs. Dose depending on the length of the lesion/scar, 1-4 ml of ICG was injected intradermally (5 mg/ml). Duration of the whole procedure about 20 - 30 minutes.
After ICG injection the possible draining lymphatic basins from the primary scar (i.e. axillae, inguinal, popliteal and neck regions) are scanned with the VS3-3DHD camera and all transcutaneous fluorescence spots recorded in the CRF. The scanning is discontinued after a maximum of 15 minutes regardless of findings.
Diagnostic Test: VS3 - 3DHD camera
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 ).
Other Name: Indocyanin green (ICG)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545334
|Contact: Radu Olariu, MDfirstname.lastname@example.org|
|Contact: Ioana Lese, MDemail@example.com|
|Inselspital, University Hospital Bern, University of Bern||Recruiting|
|Bern, Kanton Bern, Switzerland, 3010|
|Contact: Radu Olariu +41316328014 firstname.lastname@example.org|
|Contact: Ioana Lese +41316328014 email@example.com|
|Study Director:||Mihai A. Constantinescu, Professor||Director of Clinic for Plastic and Reconstructive Surgery, Inselspital Bern, Switzerland|
|Principal Investigator:||Radu Olariu, MD||Deputy chief physician of Clinic for Plastic and Reconstructive Surgery, Inselspital Bern, Switzerland|