NCT07147452Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 44 (estimated)
- First submitted
- 22 Aug 2025
- Start date
- 1 Aug 2017
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Hospital del SAS de Jerez
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07147452
What you commit to
- Study type: Observational
- Planned participants: 44
- From 1 Aug 2017 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with gastric cancer recurrence, those diagnosed with other active neoplasms, metastatic disease at diagnosis, as well as patients with Siewert type I and II gastrooesophageal junction carcinoma. Neoadjuvant treatment was not considered an exclusion criterion.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univesrsity Hospital of Jerez Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.