Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
- Conditions
- Recurrent Melanoma
- Sponsor
- Stanford University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Sentinel Lymph Nodes (SLN) Mapping
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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).
Investigators
Ralph Greco
Johnson and Johnson Professor of Surgery
Stanford University
Eligibility Criteria
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
Arms & Interventions
Sentinel Lymph Node (SLN) Detection
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.
Intervention: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Sentinel Lymph Node (SLN) Detection
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.
Intervention: Indocyanine green solution
Sentinel Lymph Node (SLN) Detection
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.
Intervention: Isosulfan blue (ISB)
Outcomes
Primary Outcomes
Sentinel Lymph Nodes (SLN) Mapping
Time Frame: 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.