Clinical trial · Interventional
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma
NCT01898403CI-TRIAL-00027775completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC). Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green solution | Drug | — | UNRESOLVED |
| Isosulfan blue (ISB) | Drug | — | UNRESOLVED |
| Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node (SLN) Detection
- description
- All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
- interventionNames
- Drug: Indocyanine green solution
- Drug: Isosulfan blue (ISB)
- Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Primary outcomes (1)
- measure
- Sentinel Lymph Nodes (SLN) Mapping
- timeFrame
- Up to 1 year
- description
- Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and willingness to sign informed consent document * Signed written informed consent * Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB) * 18 years of age or older * Complete blood count (CBC) and metabolic panel within 6 months Exclusion Criteria: * History of hepatic or renal failure * Allergy to iodine containing products * Pregnant or may be pregnant * Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements * Undergoing dialysis
References
Publications (0)
Data not yet available
No reference posted for this study.