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

NCT01898403 — Not applicable, Completed, 50 participants, Stanford University

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Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma

Registry	NCT01898403
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	50 (Actual)
Sponsor	Stanford University (Other); collaborators: National Cancer Institute (NCI)
Conditions	Recurrent Melanoma
Interventions	Indocyanine green solution, Isosulfan blue (ISB), Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) (Drug, diagnostic test)
Dates	start 2013-06-01, primary completion 2014-06-01, completion 2015-04-01, first posted 2013-07-12, last updated 2017-05-24
Locations	1 site in United States

-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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+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).

+Arms and interventions

Arm	Type	Interventions	Description
Sentinel Lymph Node (SLN) Detection	Experimental	Drug: Indocyanine green solution; Drug: Isosulfan blue (ISB); Diagnostic Test: 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.

Indocyanine green solution (Drug), also known as IC-GREEN (ICG), ICG solution: Administered peri-tumoral and intradermally
Isosulfan blue (ISB) (Drug), also known as Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide: Administered peri-tumoral and intradermally
Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) (Diagnostic test), also known as TSC lymph node mapping

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Sentinel Lymph Node (SLN) Detection
Started	50
Completed	50
Not completed	0

Outcome results

Sentinel Lymph Nodes (SLN) Mapping (Primary), Number, Sentinel lymph nodes: Sentinel Lymph Node (SLN) Detection by Isosulfan Blue 25; Sentinel Lymph Node (SLN) Detection by Indocyanine Green 25; Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy 25

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Sentinel Lymph Node (SLN) Detection	0/50 (0.0%)	0/50 (0.0%)	5/50 (10.0%)

Other adverse events by term

Term	Organ system	Sentinel Lymph Node (SLN) Detection
Infection	Infections and infestations	1/50
Seroma	Injury, poisoning and procedural complications	4/50

+Locations (1)

Facility	City	Country	Status
Stanford University Hospitals and Clinics	Stanford, California	United States

+Investigators

Ralph Greco, Principal investigator, Stanford University Hospitals and Clinics

+Funding

NIH grants: P30CA124435