N/A
Completed N=50
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
Recurrent Melanoma
Source: ClinicalTrials.gov NCT01898403 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Sentinel Lymph Nodes (SLN) Mapping — 25; 25; 25; 4 Sentinel lymph nodes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sentinel Lymph Nodes (SLN) Mapping |
25; 25; 25; 4; 0; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01898403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.