Conditions: Recurrent Melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

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).

Arms:
arm 1: 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.

Interventions: intervention 1: Indocyanine green solution intervention 2: Isosulfan blue (ISB) intervention 3: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Intervention descriptions: intervention 1: Administered peri-tumoral and intradermally intervention 2: Administered peri-tumoral and intradermally intervention 3: None

Protocol document: