Comparing SLNE With or Without Preoperative Hybrid SPECT/CT in Melanoma
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|ClinicalTrials.gov Identifier: NCT03683550|
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : December 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Procedure: SLNE with preoperative hybrid SPECT/CT Procedure: Standard SLNE||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||836 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial Comparing Sentinel Lymph Node Excision (SLNE) With or Without Preoperative Hybrid Single-photon Emission Computed Tomography/Computed Tomography (SPECT/CT) in Melanoma|
|Actual Study Start Date :||September 25, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2024|
SLNE with preoperative hybrid SPECT/CT
Procedure: SLNE with preoperative hybrid SPECT/CT
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.
Active Comparator: Standard
Standard SLNE (with planar preoperative lymphoscintigraphy)
Procedure: Standard SLNE
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.
- Distant free metastasis survival (DFMS) [ Time Frame: 6 years ]The number of patients free of distant metastasis after randomization in arm A compared to DFMS in arm B.
- Overall survival (OS) [ Time Frame: 6 years ]Overall Survival (OS) of a patient defined as the time frame start of run-in phase until documented date of death
- Disease-free survival (DFS) [ Time Frame: 6 years ]The number of patients alive and free of disease after randomization in arm A compared to DFS in arm B.
- False negative rate of SLN [ Time Frame: 3 years ]Rate of local relapse within a 12 month follow-up period (false negative rate of sentinel lymph nodes [SLN])
- Sensitivity [ Time Frame: 3 years ]Number of positive SLN
- Complication rate [ Time Frame: 6 years ]Intraoperative and postoperative complications due to SLNE
- Quality of Life (QoL) [ Time Frame: 6 years ]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.
- Quality adjusted life years (QALY) [ Time Frame: 6 years ]Assessing the health economic relevance
- Number of inpatient days [ Time Frame: 6 years ]To calculate the cost of the two treatment options the number of inpatient days will be counted and compared for each treatment arm.
- Overall costs during hospital stays [ Time Frame: 6 years ]Overall costs during hospital stays will be summed up and compared.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 years ]Intervention-related safety events will be documented during the trial period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683550
|Contact: Joachim Klode, MDemail@example.com|
|Contact: Ingo Stoffels, MDfirstname.lastname@example.org|
|Medizinische Hochschule Hannover||Not yet recruiting|
|Hannover, Niedersachsen, Germany, 30625|
|Contact: Ralf Gutzmer, MD email@example.com|
|Principal Investigator: Ralf Gutzmer, MD|
|Department of Dermatology, University Hospital Essen||Recruiting|
|Essen, NRW, Germany, 45122|
|Contact: Joachim Klode, MD|
|Contact: Ingo Stoffels, MD|
|Principal Investigator: Joachim Klode, MD|
|Principal Investigator: Ingo Stoffels, MD|
|Hospital Augsburg, Department of Dermatology||Not yet recruiting|
|Augsburg, Germany, 86156|
|Contact: Welzel Julia, Prof. Dr. firstname.lastname@example.org|
|Vivantes Hospital Berlin Neukölln||Not yet recruiting|
|Berlin, Germany, 12351|
|Contact: Uwe Hillen, Prof. Dr. email@example.com|
|Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology||Not yet recruiting|
|Dresden, Germany, 01067|
|Contact: Uwe Wollina, Prof. Dr. Wollina-Uw@khdf.de|
|University Hospital Göttingen, Department of Dermatology||Not yet recruiting|
|Göttingen, Germany, 37075|
|Contact: Lutz Kretschmer, Prof. Dr. firstname.lastname@example.org|
|University Hospital Heidelberg, Department of Dermatology||Not yet recruiting|
|Heidelberg, Germany, 69120|
|Contact: Patrick Gholam, Dr. Patrick.Gholam@med.uni-heidelberg.de|
|University Hospital Lübeck, Department of Dermatology||Not yet recruiting|
|Lübeck, Germany, 23538|
|Contact: Birgit Kahle, Prof. Dr. Birgit.Kahle@uksh.de|
|Principal Investigator:||Ingo Stoffels, MD||Department of Dermatology, University Hospital Essen|
|Principal Investigator:||Joachim Klode, MD||Department of Dermatology, University Hospital Essen|