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

Stanford University

Status: Completed

Conditions: Recurrent Melanoma

Treatments: Drug: Indocyanine green solution; Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC); Drug: Isosulfan blue (ISB)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01898403

IRB-27319

P30CA124435 (U.S. NIH Grant/Contract)

MEL0010 (Other Identifier)

NCI-2013-01286 (Registry Identifier)

Details and patient eligibility

About

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.

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Sentinel Lymph Node (SLN) Detection

Experimental group

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.

Treatment:

Drug: Isosulfan blue (ISB)

Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Drug: Indocyanine green solution