Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma
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|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Mapping of the Sentinel Lymph Nodes (SLN)
time frame: Up to 1 year
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
|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).|
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