Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.

NCT06261983 | Recruiting

• 1 other identifier: 2019111032
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe

Outcome Measures

Primary Outcomes (1)

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

  Six years

Study Arms (1)

Patients diagnosed with oral squamous cell carcinoma at stages I-II

The patients underwent sentinel node biopsy and posterior neck dissection

Procedure: Sentinel node biopsy guided by magnetic probe

Interventions

Sentinel node biopsy guided by magnetic probe PROCEDURE

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

Patients diagnosed with oral squamous cell carcinoma at stages I-II

Eligibility Criteria

• Age: 29 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Donostia: lead

Study Sites (1)

Josué Hernando Vázquez

Donostia / San Sebastian, Guipuzkoa, 20011, Spain

RECRUITING

Central Study Contacts

Josué Hernando, PhD, DDS

CONTACT

0034 675825482; josue.hernando@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DDS

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: October 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

ES (1)