Clinical trial · Interventional
Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Comparison result lymphoscintigraphy with ICG lymphography
- description
- 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.
- interventionNames
- Diagnostic Test: Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)
Primary outcomes (1)
- measure
- Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.
- timeFrame
- one hour
- description
- To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLese I, Leckenby JI, Taddeo A, Constantinescu M, Olariu R. Lymph node identification in skin malignancy using indocyanine green transcutaneously study: Study protocol for a diagnostic accuracy study. Medicine (Baltimore). 2019 Nov;98(44):e17839. doi: 10.1097/MD.0000000000017839. PMID 31689874