Overview

This trial is active, not recruiting.

Conditions recurrent melanoma, stage ia melanoma, stage ib melanoma, stage iia melanoma, stage iib melanoma, stage iic melanoma, stage iiia melanoma, stage iiib melanoma, stage iiic melanoma, stage iv melanoma
Treatments indocyanine green solution, isosulfan blue, lymph node mapping, sentinel lymph node biopsy
Sponsor Stanford University
Collaborator National Cancer Institute (NCI)
Start date June 2013
End date August 2014
Trial size 50 participants
Trial identifier NCT01898403, 27319, MEL0010, NCI-2013-01286, P30CA124435

Summary

This clinical trial studies lymph node mapping using indocyanine green solution in diagnosing patients with malignant melanoma. Diagnostic procedures, such as lymph node mapping using indocyanine green solution, may help find out how far the melanoma has spread and may help in planning cancer treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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).
indocyanine green solution IC-GREEN
Given peri-tumoral and intradermally
isosulfan blue Lymphazurin
Given peri-tumoral and intradermally
lymph node mapping
Undergo lymph node mapping
sentinel lymph node biopsy sentinel node biopsy
Undergo SNLB

Primary Outcomes

Measure
Mapping of the Sentinel Lymph Nodes (SLN)
time frame: Up to 1 year

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

Inclusion Criteria: - Ability to understand and willingness to sign informed consent document - Signed written informed consent - Patients with malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB) - Complete blood count (CBC) and metabolic panel within 6 months Exclusion Criteria: - History of hepatic or renal failure - Allergy to iodine containing products - Patients who are pregnant or may be pregnant - Patients with psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements

Additional Information

Official title Testing the Efficacy of Indocyanine Green Imaging ( ICG-SPY ) in the Identification of Sentinel Lymph Nodes ( SLN ) in Patients With Malignant Melanoma
Principal investigator Ralph Greco
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Stanford University.