Melanoma has become a growing interdisciplinary problem in public health worldwide. It characteristically disseminates in an orderly progression through lymphatic channels to the regional lymph node and then to more distant sites. Sentinel lymph node excision (SLNE) is probably the most important diagnostic and potentially therapeutic procedure for melanoma patients. This is a randomized, open-label, multi-center, superiority, 2-parallel arms trial comparing sentinel lymph node excision with or without preoperative hybrid single photon emission computed tomography/computed tomography in patients with malignant melanoma.
The presence of regional lymph node involvement is the single most important prognostic factor, lowering the 5-year survival rate to approximately 50%. Recommendations for the use of SLNE for primary melanoma are included in the current American Joint Committee on Cancer guidelines. Critics argue that the routinely performed SLNE is a cost intensive surgical intervention with potential morbidity that does not offer patients any advantage in overall survival. The current gold standard for detection and targeted extirpation of the sentinel lymph node (SLN) is preoperative lymphoscintigraphy as an imaging technique to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy. Single-photon emission computed tomography/computed tomography (SPECT/CT) provides complementary functional and anatomical information and has been shown to be superior to planar imaging in a number of indications. It can provide valuable information before sentinel lymph node biopsy and advocate its use in a range of tumors such as truncal and head and neck melanomas. The objective of the planned multi-center randomized prospective trial is to compare distant metastasis-free survival (DMFS) in patients with cutaneous melanoma between sentinel lymph node excision with versus without preoperative SPECT/CT imaging and metastatic node detection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Single-photon emission computed tomography/computed tomography (SPECT/CT) provides complementary functional and anatomical information and has been shown to be superior to planar imaging in a number of indications. It can provide valuable information before sentinel lymph node biopsy and advocate its use in a range of tumors such as truncal and head and neck melanomas.
The current gold standard for detection and targeted extirpation of the sentinel lymph node (SLN) is preoperative lymphoscintigraphy. Lymphoscintigraphy (sentinel lymph node mapping) is an imaging technique used to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy.
Department of Dermatology, University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Hospital Augsburg, Department of Dermatology
Augsburg, Germany
Vivantes Hospital Berlin Neukölln
Berlin, Germany
Distant free metastasis survival (DFMS)
The number of patients free of distant metastasis after randomization in arm A compared to DFMS in arm B.
Time frame: 6 years
Overall survival (OS)
Overall Survival (OS) of a patient defined as the time frame start of run-in phase until documented date of death
Time frame: 6 years
Disease-free survival (DFS)
The number of patients alive and free of disease after randomization in arm A compared to DFS in arm B.
Time frame: 6 years
False negative rate of SLN
Rate of local relapse within a 12 month follow-up period (false negative rate of sentinel lymph nodes \[SLN\])
Time frame: 3 years
Sensitivity
Number of positive SLN
Time frame: 3 years
Complication rate
Intraoperative and postoperative complications due to SLNE
Time frame: 6 years
Quality of Life (QoL)
Measure of health outcome by questionnaire. The EuroQol-5 Dimensions-5 Level (EQ-5D-5L) questionnaire consists of five HrQoL dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with each dimension specifying five levels of severity \[no (level 1), slight (level 2), moderate (level 3), severe (level 4), and extreme problems/unable (level 5)\], which allows the description of 3125 health states.
Time frame: 6 years
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NONE
Enrollment
836
University Hospital Bonn
Bonn, Germany
Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology
Dresden, Germany
Universitätsklinik Dresden
Dresden, Germany
Universitätskliniken Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Giessen
Giessen, Germany
University Hospital Göttingen, Department of Dermatology
Göttingen, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
...and 3 more locations
Quality adjusted life years (QALY)
Assessing the health economic relevance
Time frame: 6 years
Number of inpatient days
To calculate the cost of the two treatment options the number of inpatient days will be counted and compared for each treatment arm.
Time frame: 6 years
Overall costs during hospital stays
Overall costs during hospital stays will be summed up and compared.
Time frame: 6 years
Incidence of Treatment-Emergent Adverse Events
Intervention-related safety events will be documented during the trial period
Time frame: 6 years