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

Not Applicable

Completed

• Conditions: Recurrent Melanoma
• Interventions: Drug: Indocyanine green solution; Drug: Isosulfan blue (ISB); Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

• Registration Number: NCT01898403
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-12
• Primary Completion: 2014-06
• Study Completion: 2015-04
• Status Verified: 2015-06
• Results First Submitted: 2017-02-24
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-05-24
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node (SLN) Detection	Indocyanine green solution	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.
Sentinel Lymph Node (SLN) Detection	Isosulfan blue (ISB)	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.
Sentinel Lymph Node (SLN) Detection	Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)	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.

Primary Outcome Measures

Name	Time	Method
Sentinel Lymph Nodes (SLN) Mapping	Up to 1 year	Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States