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Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.

Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe in Squamous Cell Oral Carcinoma: a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06261983
Acronym
SentiMag
Enrollment
24
Registered
2024-02-15
Start date
2018-10-01
Completion date
2024-12-31
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe

Brief 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 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.

Interventions

PROCEDURESentinel node biopsy guided by magnetic probe

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

Sponsors

Hospital Donostia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Oral squamous cell carcinoma T1-T2, cN0. * Absence of alterations to iron metabolism.

Exclusion criteria

* Previous neck surgery. * Treatment with iron chelators. * Pregnant

Design outcomes

Primary

MeasureTime frame
The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV).Six years

Countries

Spain

Contacts

Primary ContactJosué Hernando, PhD, DDS
josue.hernando@gmail.com0034 675825482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026