Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic ProbeSentiMagNCT06261983
Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.
An observational study of Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe, run by Hospital Donostia at 1 site in Spain.
Trial summary
Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this… Read more about this study
- Who is it for?
- Ages 29 to 85 years
- Conditions the study is for
- Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe
- What is being tested?
- Sentinel node biopsy guided by magnetic probe
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 29 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited consecutively when diagnosed with oral squamous cell carcinoma at clinical stages I-II by biopsy and magnetic resonance. All patients were intervened by the same surgeon at the Department of Maxillofacial Surgery at Donostia University Hospital.
Who may be able to join
- Oral squamous cell carcinoma T1-T2, cN0.
- Absence of alterations to iron metabolism.
Who cannot join
- Previous neck surgery.
- Treatment with iron chelators.
- Pregnant
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Josué Hernando Vázquez
Donostia / San Sebastian, Guipuzkoa, 20011
Josué Hernando, PhD, DDS, 0034 675825482, josue.hernando@gmail.com
About this study
Official title: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe in Squamous Cell Oral Carcinoma: a Prospective Observational Study
Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.
- Being tested
- Sentinel node biopsy guided by magnetic probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node biopsy guided by magnetic probeProcedure or surgery
Sentinel nodes exeresis guided by magnetic probe after injection submucosally and peritumorally of super-para-magnetic contrast. Standard neck dissection (levels I-II) were carry out after sentinel node biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with oral squamous cell carcinoma at stages I-II | The patients underwent sentinel node biopsy and posterior neck dissection Receives: Procedure: Sentinel node biopsy guided by magnetic probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV).
Measured: Six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Oct 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic ProbeStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Donostia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Hernando, Hospital Donostia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261983
- Sponsor's protocol ID
- 2019111032
- Acronym
- SentiMag
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe in Squamous Cell Oral Carcinoma: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06261983
- Acronym / sponsor ID
- SentiMag / 2019111032
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospital DonostiaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with oral squamous cell carcinoma at stages I-II | – | Procedure: Sentinel node biopsy guided by magnetic probeThe patients underwent sentinel node biopsy and posterior neck dissection |
Who may qualify
- Ages
- 29 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited consecutively when diagnosed with oral squamous cell carcinoma at clinical stages I-II by biopsy and magnetic resonance. All patients were intervened by the same surgeon at the Department of Maxillofacial Surgery at Donostia University Hospital.
Key inclusion criteria (2 listed)
- Oral squamous cell carcinoma T1-T2, cN0.
- Absence of alterations to iron metabolism.
Key exclusion criteria (3 listed)
- Previous neck surgery.
- Treatment with iron chelators.
- Pregnant
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 |
|---|---|---|
| Sentinel node biopsy guided by magnetic probeSentinel nodes exeresis guided by magnetic probe after injection submucosally and peritumorally of super-para-magnetic contrast. Standard neck dissection (levels I-II) were carry out after sentinel node biopsy | Procedure or surgery | Patients diagnosed with oral squamous cell carcinoma at stages I-II |
Primary outcome
The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV).
Time frame: Six years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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.
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 Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe, run by Hospital Donostia 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josué Hernando, PhD, DDS (0034 675825482, josue.hernando@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV). (time frame: Six years). 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 15 Feb 2024.