Clinical Trial

Sentinel Lymph Node Detection in Gastric Cancer Using a Dual Tracer (Superparamagnetic Iron Oxide and Methylene Blue): A Prospective Study With Histological and OSNA Validation

Study acronym: SLN_GC_SPIO
Active, Not Recruiting
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Summary
Gastric cancer (GC) remains an oncological challenge, where lymph node involvement is a key prognostic factor. Sentinel lymph node (SLN) mapping may improve staging and reduce surgical morbidity. This study evaluated a dual-tracer technique - superparamagnetic iron oxide (SPIO) and methylene blue - for ex vivo SLN detection in GC, analysed the performance of one-step nucleic acid amplification (OSNA) versus conventional histology and applied pooling analysis with OSNA in non-sentinel nodes. The aim of this prospective study was, firstly, to evaluate the accuracy of ex vivo SLN detection using a novel dual tracer: SPIO not previously used for this pathology, combined with methylene blue. Secondly, to perform a diagnostic concordance analysis between the results of the conventional histological haematoxylin-eosin (H-E) study versus the OSNA (One Step Nucleic Acid Amplification) molecular method, for the detection of lymph node metastases in patients with gastric cancer undergoing surgery with curative intent and lymphadenectomy.
Trial Details
NCT Number NCT07147452
Lead Sponsor Hospital del SAS de Jerez
Collaborators: Sysmex España
Conditions Gastric Cancer (GC), Sentinel Lymph Node Biopsy (SLNB)
Enrollment 44 participants
Start Date 2017-08-01
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-08 (estimated)
Updated on ClinicalTrials.gov 2025-08-29