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

Stage IV Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01898403
• Other study ID #: MEL0010
• Secondary ID: NCI-2013-0128627
• Status: Active, not recruiting
• Phase: N/A
• First received: July 3, 2013
• Last updated: July 28, 2014
• Start date: June 2013

Study information

• Verified date: July 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• 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

Intervention

Drug:
• indocyanine green solution
Given peri-tumoral and intradermally
• isosulfan blue
Given peri-tumoral and intradermally

Procedure:
• lymph node mapping
Undergo lymph node mapping
• sentinel lymph node biopsy
Undergo SNLB

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mapping of the Sentinel Lymph Nodes (SLN)	SLN will be identified and mapped using indocyanine green solution, isosulfan blue, and TSC. Participants will undergo peri-tumoral, intradermal injection of ISB AND ICG, in addition intra-operatively the SPY camera will be ued to identify SLN and take images.	Up to 1 year	No