NCT01898403

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Recurrent Melanoma

Interventions

Type	Name	Description
DRUG	Indocyanine green solution	Administered peri-tumoral and intradermally
DRUG	Isosulfan blue (ISB)	Administered peri-tumoral and intradermally
DIAGNOSTIC_TEST	Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2015-04-01
• First posted: 2013-07-12
• Last updated: 2017-05-24
• Results posted: 2017-05-24

Locations

1 site across 1 country: United States