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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

NCT07147452 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

  • Gastric Cancer (GC)
  • Sentinel Lymph Node Biopsy (SLNB)

Interventions

PROCEDURE

Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene Blue

Participation in the study did not alter the indications or standard surgical technique. The only additional intervention consisted of intraoperative administration of SPIO, performed either laparoscopically or conventionally, as appropriate. Immediately after removal of the surgical specimen : Submucosal instillation of methylene blue was then performed at the tumour periphery

DIAGNOSTIC_TEST

OSNA AND H-E

Analysed the performance of one-step nucleic acid amplification (OSNA) versus conventional histology and applied pooling analysis with OSNA in non-sentinel nodes

Sponsors & Collaborators

  • Sysmex España

    collaborator INDUSTRY

  • Hospital del SAS de Jerez

    lead OTHER

Principal Investigators

  • ESCALERA-PEREZ, RAQUEL, MD · Hospital del SAS de Jerez

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2025-08-01
Completion
2025-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147452 on ClinicalTrials.gov