Gastric Cancer (GC)SLN_GC_SPIONCT07147452
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
An observational study of Gastric Cancer (GC) and Sentinel Lymph Node Biopsy (SLNB), run by Hospital del SAS de Jerez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC), Sentinel Lymph Node Biopsy (SLNB)
- What is being tested?
- Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene Blue and OSNA AND H-E
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2017to Aug 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Univesrsity Hospital of Jerez Frontera
Jerez de la Frontera, CADIZ, 11403
About this study
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.
Read the detailed description
Observational, prospective and analytical study, carried out in a second level university hospital with 500 inpatient beds.
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.
All patients were diagnosed, treated and followed up according to the centre's standard clinical practice, following a protocol based on the scientific evidence collected in the European ESMO-ESSO-ESTRO guidelines for the management of gastric cancer Surgical procedures Participation in the study did not alter the indications or standard surgical technique. The only additional intervention consisted of intraoperative administration of SPIO (superparamagetic iron oxide)
Variables collected 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.
Statistical analysis Data were analysed using SPSS version 26.0 software (IBM Corp., Armonk, NY, USA) and EpiDat version 4.2 (Xunta de Galicia, Spain). A descriptive analysis was performed using measures of central tendency and dispersion for quantitative variables, and absolute and relative frequencies for qualitative variables. The chi-square test with correction was used to compare qualitative variables. Concordance between methods was assessed using Cohen's kappa coefficient. Diagnostic accuracy was determined by calculating sensitivity and specificity, together with their respective 95% confidence intervals according to Hanley\&McNeil. Survival curves were estimated using the Kaplan-Meier method, and differences between groups were analysed using the log-rank test. A value of p < 0.05 was considered statistically significant.
- Being tested
- Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene Blue, OSNA AND H-E
- Keywords
- GASTRIC CANCER, SENTINEL LYMPH NODE, OSNA, DUAL TRACER
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene BlueProcedure or surgery
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
OSNA AND H-EDiagnostic test
Analysed the performance of one-step nucleic acid amplification (OSNA) versus conventional histology and applied pooling analysis with OSNA in non-sentinel nodes
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH GASTRIC CANCER AND CK19+ | Not described Receives: Procedure: Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene Blue; Diagnostic Test: OSNA AND H-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: cut-off date for all patients: 15 July 2025.
Secondary outcomes (2)
Migration times of both tracers
the SLNs stained with methylene blue and/or those detected using the Sentimag® probe, previously calibrated, were dissected and extracted
Measured: Immediately after surgery
Lymph node involvement
Each lymph node identified, including the sentinels obtained in the operating theatre, was sectioned into two symmetrical halves: one for conventional histopathological analysis and the other for molecular analysis by OSNA
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Aug 2017
- Primary completion1 Aug 2025
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital del SAS de Jerez
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex España
- Responsible party
- Principal investigator, RAQUEL ESCALERA, Hospital del SAS de Jerez
- Investigators
- ESCALERA-PEREZ, RAQUEL, MD, Principal investigator, Hospital del SAS de Jerez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147452
- Sponsor's protocol ID
- SLN_GC_SPIO_RE_18
- Acronym
- SLN_GC_SPIO
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known whether there will be a plan for the IPD to be made available
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07147452
- Acronym / sponsor ID
- SLN_GC_SPIO / SLN_GC_SPIO_RE_18
- Keywords
- GASTRIC CANCER, SENTINEL LYMPH NODE, OSNA, DUAL TRACER
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital del SAS de JerezUniversity, hospital or other
- Collaborators
- Sysmex España
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Observational, prospective and analytical study, carried out in a second level university hospital with 500 inpatient beds.
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.
All patients were diagnosed, treated and followed up according to the centre's standard clinical practice, following a protocol based on the scientific evidence collected in the European ESMO-ESSO-ESTRO guidelines for the management of gastric cancer Surgical procedures Participation in the study did not alter the indications or standard surgical technique. The only additional intervention consisted of intraoperative administration of SPIO (superparamagetic iron oxide)
Variables collected 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.
Statistical analysis Data were analysed using SPSS version 26.0 software (IBM Corp., Armonk, NY, USA) and EpiDat version 4.2 (Xunta de Galicia, Spain). A descriptive analysis was performed using measures of central tendency and dispersion for quantitative variables, and absolute and relative frequencies for qualitative variables. The chi-square test with correction was used to compare qualitative variables. Concordance between methods was assessed using Cohen's kappa coefficient. Diagnostic accuracy was determined by calculating sensitivity and specificity, together with their respective 95% confidence intervals according to Hanley\&McNeil. Survival curves were estimated using the Kaplan-Meier method, and differences between groups were analysed using the log-rank test. A value of p < 0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual tracer: The infiltration of the Supermagnetic Iron Oxide (SPIO) and Methylene BlueParticipation 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 | Procedure or surgery | PATIENTS WITH GASTRIC CANCER AND CK19+ |
| OSNA AND H-EAnalysed the performance of one-step nucleic acid amplification (OSNA) versus conventional histology and applied pooling analysis with OSNA in non-sentinel nodes | Diagnostic test | PATIENTS WITH GASTRIC CANCER AND CK19+ |
Primary outcome
demographic, clinical and pathological variables
Time frame: cut-off date for all patients: 15 July 2025.
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
2 secondary outcomes
Migration times of both tracers
Time frame: Immediately after surgery
Lymph node involvement
Time frame: 6 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided. It is not yet known whether there will be a plan for the IPD to be made available
Related trials for Gastric Cancer (GC)
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
TEAS for Gastrectomy Recovery
Gastric Cancer (GC), Stomach Neoplasms
Not yet recruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6062 in Patients With Advanced Solid Tumors.
Advanced Solid Tumors, Gastric Cancer (GC)
Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
RecruitingPhase 1/2
Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma
Gastric Cancer, Gastric Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESCALERA-PEREZ, RAQUEL, MD principal investigator
Hospital del SAS de Jerez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (GC) and Sentinel Lymph Node Biopsy (SLNB), run by Hospital del SAS de Jerez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demographic, clinical and pathological variables (time frame: cut-off date for all patients: 15 July 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.