Comparing SLNE With or Without Preoperative Hybrid SPECT/CT in Melanoma

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Melanoma

Clinical Trial Details

NCT number	NCT03683550
Study type	Interventional
Source	University Hospital, Essen
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 25, 2018
Completion date	June 2025

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