N/A N=50 Diagnostic

Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

Recurrent Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT01898403 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Sentinel Lymph Nodes (SLN) Mapping — 25; 25; 25; 4 Sentinel lymph nodes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Indocyanine green solution (Drug); Isosulfan blue (ISB) (Drug); Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Sentinel Lymph Nodes (SLN) Mapping	25; 25; 25; 4; 0; 4	—

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.

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

View full record on ClinicalTrials.gov →

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.