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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Recurrent Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sentinel Lymph Node (SLN) Detection

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.

Group Type EXPERIMENTAL

Indocyanine green solution

Intervention Type DRUG

Administered peri-tumoral and intradermally

Isosulfan blue (ISB)

Intervention Type DRUG

Administered peri-tumoral and intradermally

Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Intervention Type DIAGNOSTIC_TEST

Interventions

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Indocyanine green solution

Administered peri-tumoral and intradermally

Intervention Type DRUG

Isosulfan blue (ISB)

Administered peri-tumoral and intradermally

Intervention Type DRUG

Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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IC-GREEN (ICG) ICG solution Lymphazurin N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide TSC lymph node mapping

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No