Melanoma Clinical Trial

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

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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.

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Full Description

PRIMARY OBJECTIVES:

I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

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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

Study is for people with:

Melanoma

Estimated Enrollment:

50

Study ID:

NCT01898403

Recruitment Status:

Completed

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University Hospitals and Clinics
Stanford California, 94305, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

50

Study ID:

NCT01898403

Recruitment Status:

Completed

Sponsor:


Stanford University

How clear is this clinincal trial information?

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