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 | Active Not Recruiting

• 1 other identifier: SLN_GC_SPIO_RE_18
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

GASTRIC CANCER, SENTINEL LYMPH NODE, OSNA, DUAL TRACER

Outcome Measures

Primary Outcomes (1)

• demographic, clinical and pathological variables

  For each patient included in the study, demographic, clinical and pathological variables were systematically collected: age, sex, type of neoplasm, size, tumour grade, TNM 8ed, stage, neoadjuvant treatment and degree of regression, if any. Perioperative variables such as type of intervention, type of lymphadenectomy, time of infiltration and tracer detection, operative complications, reoperation rate and hospital stay were also evaluated. During follow-up, oncological variables such as recurrence rate, mortality, overall survival and disease-free survival were analysed

  cut-off date for all patients: 15 July 2025.

Secondary Outcomes (2)

• Migration times of both tracers

  Immediately after surgery

• Lymph node involvement

  6 MONTHS

Study Arms (1)

PATIENTS WITH GASTRIC CANCER AND CK19+

Procedure: Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene Blue; Diagnostic Test: OSNA AND H-E

Interventions

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

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

PATIENTS WITH GASTRIC CANCER AND CK19+

OSNA AND H-E DIAGNOSTIC_TEST

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

PATIENTS WITH GASTRIC CANCER AND CK19+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with an indication for oncological gastric surgery who met the inclusion criteria were consecutively included in the period between August 2017 and March 2022.

You may qualify if:

• Patients over 18 years of age with a diagnosis of gastric adenocarcinoma, undergoing surgery with curative intent by total or subtotal gastrectomy, accompanied by D1, D1+ or D2 lymphadenectomy, and with preoperative positivity for cytokeratin 19 (CK19) in the tumour sample.

Sponsors & Collaborators

• Hospital del SAS de Jerez: lead
• Sysmex España: collaborator

Study Sites (1)

Univesrsity Hospital of Jerez Frontera

Jerez de la Frontera, CADIZ, 11403, Spain

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ferric oxide; Methylene Blue

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ESCALERA-PEREZ, RAQUEL, MD

  Hospital del SAS de Jerez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Surgery Department.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: August 1, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

ES (1)